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					                                                           REDOXS FAQ Log
         Category       Sub Category                             Question                                                        Response
                                                                                                     The patient must be screened AND consent must be
                                                                                                     obtained within 24 hrs of ICU admission since supplements
                                                                                                     need to be started soon after admission to ICU. If it takes
                                                                                                     too long to obtain consent, this patient should NOT be
                                       How much time do we have to obtain consent? Is it 24 hrs      randomized as there will be an unacceptable delay in
          Consent           n/a        from ICU admission?                                           starting study supplements.
                                                                                                     No, these patients are eligible. It is understood that given
                                                                                                     the patient’s organ failures, enteral feeds may not be
                                                                                                     tolerated or it may be difficult to ascertain how well the
                                                                                                     patient is going to tolerate enteral feeds. Either way, these
                                                                                                     patients should not be excluded unless they meet an
                                       What about patients in which it is difficult to assess with   exclusion criteria (i.e. absolute contraindication to enteral
                                       precision the tolerance to enteral feeding? Should these      nutrition). Remember, the study supplements are nutrients
                                       patients be excluded if feeds are not expected to be          that are infused at low rates, they are very well absorbed
          Eligibility       n/a        tolerated?                                                    even in patients that are not tolerating enteral nutrition.
                                                                                                     Yes, but ONLY if the organ failures are considered to be
                                                                                                     acute at this admission and are NOT a continuation from the
                                                                                                     previous admission to ICU. Also, remember that previous
                                       Is the patient that was admitted to ICU 2 weeks ago, was      randomization in the REDOXS study means the patient is
          Eligibility       n/a        discharged and is not re-admitted to ICU eligible?            excluded at all subsequent admissions.
                                                                                                     Yes, a patient who has cancer is eligible as long as it is not
          Eligibility       n/a        Is a patient who has cancer eligible?                         metastatic cancer or stage 4 lymphoma.
                                       For a patient with Chronic Lung Disease that may have a
                                       chronic low PF ratio, do we need to pick 2 other organ      No, for the patient with Chronic Lung Disease, a PF ration <
          Eligibility       n/a        failures?                                                   300 can be chosen as one of the organ failures.
                                                                                                   Organ failures may have started before ICU admission but
                                                                                                   MUST BE PRESENT IN THE ICU in order to meet study
                                                                                                   inclusion criteria. A patient remains eligible for enrolment
                                       What if the organ failures were present on admission to ICU even if organ failures have resolved at the time of screening
                                       but were resolved before the time of screening or           or randomization. If organ failure has occurred > 72 hours
          Eligibility       n/a        randomization?                                              prior to ICU admission, it may NOT be considered acute.

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                                                           REDOXS FAQ Log
         Category       Sub Category                             Question                                                     Response
                                                                                                   No, the actual time of admission to ICU is the ICU admission
                                                                                                   time. The 24 hour window starts from the actual ICU
                                                                                                   admission, not the time they were in the step-down ICU
                                                                                                   waiting for an ICU bed, even if they were ventilated in the
                                                                                                   step-down unit. For inclusion, the failures have to be present
                                       Some patients are admitted initially to step-down ICU and   in the ICU, even if they started in the step-down unit. The
                                       later they are transferred to the ICU. Is the step-down ICU timing of the organ failure is onset of organ failure. For
                                       considered as an ICU stay and should the time in the step- example, for the PF ratio, use the first ratio < 300 that was
          Eligibility       n/a        down ICU be calculated as an ICU stay?                      done on the ABG after they were ventilated.
                                                                                                   For patients that have been transferred to you ICU from an
                                                                                                   ICU at a different hospital, please remember the following:
                                                                                                   • The 24 hour period from ICU admission to time of consent
                                                                                                   refers to the TOTAL time the patient is in an ICU setting.
                                                                                                   That is, the 24 hour period begins at the time of ICU
                                                                                                   admission at the other hospital.
                                       For patients transferred from another ICU, how do we        • For example, if a patient is in another ICU for 4 hours and
                                       calculate the window of eligibility? From the ICU admission is subsequently transferred to you ICU, then you have 20
          Eligibility       n/a        here or at the other hospital?                              hours remaining to obtain consent for enrolment.
                                       I am screening a patient that had a closed head injury many
                                       years ago and has had a reasonable level of functioning at
                                       home. He was admitted to the hospital for renal colic, and
                                       now has urosepsis. Does the previous head injury exclude No, the patient does not meet an exclusion criteria. Patients
          Eligibility       n/a        him from the study?                                         with ACUTE severe acquired brain injury are excluded.
                                       Regarding the low platelet count inclusion criteria         This condition is NOT considered acute in terms of organ
                                       (<50mm^3), can a chemo-induced or chronic                   failure. But this type of patient would be considered eligible if
                                       thrombocytopenia be considered in the determination of the they met 2 of the remaining organ failures, and did not meet
          Eligibility       n/a        eligibility of the patient?                                 any exclusion criteria.
                                                                                                   Yes, such a patient is eligible for enrolment as he/she will
                                                                                                   likely undergo GI surgery shortly after admission to ICU. In
                                                                                                   either case the enteral supplements can be started early
                                                                                                   even if there is hesitancy to feed enteral nutrition.
                                                                                                   Remember, the enteral supplements are infused at a low
                                                                                                   rate (20ml/hr), and if there are concerns in the first day or so,
                                                                                                   the enteral supplements could be infused at a lower rate,
                                       Is a patient who has a GI perforation and is undergoing     perhaps 10ml/hr. Parenteral supplements can be started
          Eligibility       n/a        surgery eligible for enrolment into the study?              right away.

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                                                              REDOXS FAQ Log
         Category      Sub Category                                   Question                                                      Response
                                          After I log-in, I get a message saying “Session is expired, log
                                          in again” and when I log in again, I still get the same         You may need to change your internet settings to allow
                                          message. I have tried changing my password but I still get cookies. Please see instructions that will be posted on our
        EDC System         Log-in         the error message.                                              website.
                                                                                                          To delete extra days, go to the Patient Status Page, click on
                                          I accidentally added extra days for the daily data field. How the last day that you entered data on and scroll down to the
                                          do I delete extra days from the daily data? Can I change the bottom, clock on the DELETE DAY button. Changes to the
                                          data entered on the screening forms after I have randomized screening data after you have randomized can only be made
        EDC System        General         a patient?                                                      by CERU.
                                                                                                          Because the duration of data collection is until day 30 or until
                                                                                                          ICU discharge or until time of death, the system identified
                                          The family decided that treatment/care should be withdrawn that the data missing for the period of time before death
                                          and as such data collection stopped. The patient died in the actually occurred (from the start of the flow sheet until death)
                                          afternoon the following day. When I try to enter the date of thus the error message. You will not have any data to enter
                                          death in the outcomes section, I receive an error message because data collection was stopped. In the eCRF on the
                                          indicating that no data has been entered on the date of         day of death you will need to click “n/a” or “no” for each data
        EDC System       Daily Data       death. What do I do?                                            component.

                                                                                                          No, unused and returned or expired study supplements and
                                                                                                          empty vials do not need to be kept for monitoring purposes.
                                                                                                          Record unused product returned to the pharmacy or expired
                                          Do returned, unused study supplements and empty vials           product in the Nutrient Accountability Log. Please dispose
         Pharmacy           n/a           need to be kept for monitoring purposes?                        as per your pharmacy’s drug destruction policy.
                                                                                                          Standard amounts of selenium (up to a maximum of
                                                                                                          60mcg/day) and zinc (up to a maximum of 5mg/day) that are
                                                                                                          already present in the parenteral solutions are allowed.
                                                                                                          Enteral or parenteral supplements/preparations that contain
                                          Are standard amounts of vitamins and minerals that are          amounts of zinc (or selenium) higher than those above
          Nutrition   Vitamins/minerals   present in enteral and parenteral nutrition allowed?            should not be allowed (e.g. maternal supplements).

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                                                                 REDOXS FAQ Log
         Category        Sub Category                                  Question                                                      Response

                                                                                                            Yes! You may follow this method: Divide the prescribed
                                                                                                            volumes needed over the remaining hours in study day 1
                                                                                                            and infuse the supplements at this rate. Study day 2: infuse
                                                                                                            at regular rate (i.e. 10ml/hr parenteral, 20ml/hr enteral.
                                                                                                            Example: Patient admitted to ICU on July 23 @ 1500 hrs,
                                                                                                            supplements started at 1700 hrs and flowsheet runs from
                                                                                                            0700-0700 hrs. Number of remaining hours in study day 1
                                                                                                            (from 1700 on July 23 to 0659 on July 24) = 14 hours.
                                                                                                            Divide the prescribed volume of enteral supplements over
                                                                                                            the 14 hours. For enteral supplements, this is 480ml/14 = 34
                                             The template study supplement orders were not very clear       ml/hr until 0659 on July 24, then at 0700 restart at the
                                             for study day 1. Can we not calculate the number of            regular rate (20ml/hr) for 24 hours (study day 2). Similarily
                                             remaining hours and then divide the prescribed volumes         for parenteral.
    Study Supplements        Orders          over these hours instead of doubling the rate?

                                                                                                          No, you do not need to fill in a protocol violation form but you
                                                                                                          must write a comment on your daily checklist. When you
                                                                                                          enter this volume online, you will be prompted to add the
                                             What if the volume of supplements administered within a 24 reason why the volume exceeded the prescribed. In the
                                             hour period is more than the prescribed volume, do I need to event of a major discrepancy (e.g. entire 24 hour volume
    Study Supplements   Protocol Violation   fill out a protocol violation form?                          received in 1 hour) please contact the Project Leader.

                                                                                                            Yes, in the event of an emergency drug, the infusion of the
                                                                                                            parenteral study supplements can be stopped for a couple of
                                             Can a central line that is used for parenteral study           hours as long as the infusion of supplements is resumed and
    Study Supplements       Delivery         supplements be used for emergency drug use?                    doubled up to make up the volumes (after proper flushing).
                                                                                                            Yes. In the event that the parenteral study supplements get
                                             Duration of study supplements, is it 28 days from the time     started days before the enteral study supplements, the 28
    Study Supplements       Duration         that the first supplement started?                             days is from the start of the parenteral supplements.
                                                                                                            No. Currently there is no stability data for the study
                                                                                                            supplements administered via a conventional Y-set with PN
                                                                                                            admixtures, heparin/insulin infusions or other medications.
                                             Can parenteral supplements be piggybacked in through the As such, piggybacking the study supplements with heparin or
                                             same IV line that is infusing PN containing heparin or insulin insulin should be avoided. In this case you must use a
    Study Supplements       Delivery         or through the same line that is infusing heparin or insulin? separate line for the parenteral supplements.

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                                                           REDOXS FAQ Log
         Category       Sub Category                             Question                                                       Response
                                                                                                   (1) Enteral Study Supplements: If feeding tube has been
                                                                                                   removed during extubation, the enteral study supplements
                                                                                                   will stop. If the feeding tube remains in place, enteral
                                                                                                   supplements should continue. If the patient is re-ventilated
                                                                                                   and/or a feeding tube re-introduced, the enteral supplements
                                                                                                   should be restarted. NOTE: It is encouraged that the clinical
                                                                                                   team leave the feeding tube in place for 24 hours or more
                                                                                                   after extubation until it is certain that the patient will be
                                                                                                   transferred to the ward and/or that the patient is able to take
                                                                                                   in adequate PO intake.
                                                                                                   (2) Parenteral Study Supplements: If the enteral study
                                       I enrolled a REDOXS patient 2 days ago, but the patient has supplements have been stopped, you should continue with
                                       unexpectedly improved and has just been extubated. What the parenteral study supplements.
    Study Supplements     Duration     do I do?
                                                                                                        If the patient gets discharged from ICU < 5 days from ICU
                                                                                                        admission, the supplements must continue on the ward until
                                                                                                        the patient receives a total of 120 hours from the time
                                       Could you please clarify the duration of study supplements       supplements are started. That is, if IV access and/or GI
                                       for a patient that is discharged from ICU to the ward at < 5     access is available, the supplements must continue until the
    Study Supplements     Duration     days from ICU admission?                                         patient has received 120 hours of the study supplements.
                                       I have a REDOXS patient who received study supplements
                                       for 24 hours, but was then extubated and discharged to the
                                       floor. Parenteral supplements are being continued on the         Yes, restart enteral study supplements. Since the patient is
                                       floor for 120 hours from the time of randomization. The next     on the floor and spent < 5 days in the ICU, the enteral study
                                       day a feeding tube was reintroduced, should I start enteral      supplements would only run until the end of 120 hours from
    Study Supplements     Duration     supplements? For how long?                                       the time of randomization.
                                       I have a patient who received parenteral supplements for 28      No, the time period for administering the study supplements
                                       days but did not receive enteral supplements for all of the 28   is until 28 days post randomization. Don’t forget, data
                                       days. Should the patient continue to receive enteral             collection continues until day 30 if the patient remains in the
    Study Supplements     Delivery     supplements until they have received 28 days in total?           ICU.

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                                                                      REDOXS FAQ Log
         Category            Sub Category                                   Question                                                      Response
                                                                                                               Yes, call this study day 1. Since study day 1 is from ICU
                                                                                                               admission until the end of your flowsheet, it may be that the
                                                                                                               patient does not get randomized until the next day and that
                                                A patient may not be randomized on study day 1 and may         supplements do not get started until the next day (e.g.
                                                not receive any supplements on this day. Do I still call this patient is admitted in the middle of the night or early
      Data Collection         Study Day         study day 1?                                                   morning).
                                                Do I calculate the calories from propofol even if patients are No, calories from propofol are to be calculated only if the
      Data Collection       Daily Nutrition     not receiving enteral or parenteral nutrition?                 patient is receiving enteral or parenteral nutrition.
                                                                                                               We are only interested in hydrocortisone (=Solu-cortef) and
                                                                                                               other medications listed (i.e. Activated Protein C, insulin and
                                                For concomitant medications, what about other steroids such motility agents). You do NOT need to record Decatron or
      Data Collection   Concomitant Medications as Decadron or Solumedrol? How so I record these?              Solumedrol.
                                                                                                             Yes, if the GRV is measured it should be recorded whether
                                                   Are we to measure/record gastric residual volumes if the  or not the patient is being tube fed. If the GRV is not
      Data Collection          Daily Data          patient is not being tube fed?                            measured, there is an option to select n/a on the eCRF.
                                                                                                             Yes. The screening # is assigned once a patient is screened
                                                                                                             for the study. The enrolment # is the number assigned at
                                                                                                             randomization. The CR # refers to the unique ID# that is
                                                                                                             assigned to each patient that is KGH we call
                                                   Does each patient have a screening #, enrolment # and CR it the Chart Registry # (CR#). Please refer to page 12 of the
      Data Collection           General            #?                                                        Pharmacy Manual.
                                                                                                             No documentation is required because the readmission is >
                                                                                                             48 hours from ICU discharge. As outlined in the REDOXS
                                                                                                             Implementation Manual (page 7), if a patient is readmitted to
                                                                                                             your ICU WITHIN 48 HOURS of discharge, consider this to
                                                                                                             be a continuation of the previous stay. Restart the study
                                                                                                             supplements and continue to collect data and consider the
                                                                                                             reason for readmission to ICU as a Serious Adverse Event.
                                                                                                             If the patient is readmitted to your ICU after 48 hours of
                                                   What documentation is required if a REDOXS patient is re- discharge, this is not considered to be a continuation of the
      Data Collection        Re-admission          admitted to the ICU > 48 hours after the ICU discharge?   previous stay.

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                                                                 REDOXS FAQ Log
         Category        Sub Category                                  Question                                                             Response
                                                                                                             (1) If enteral nutrition continues past ICU discharge, then
                                                                                                             enteral nutrition stop date/time = ICU discharge date/time
                                                                                                             (pg. 29 of Implementation Manual)
                                                                                                             (2) If the patient is still in the ICU past day 30 and is still
                                             What is the enteral nutrition stop date?                        receiving enteral nutrition, the enteral nutrition stop date/time
                                             (1) If the patient continues enteral feeds after being          = day 30 date/time. Enteral nutrition stop time is the time
                                             discharged from ICU?                                            your flowsheet ends.
                                             (2) If the patient remains in the ICU beyond day 30 and is      In both cases, please enter the actual enteral nutrition stop
                                             still receiving enteral feeds?                                  date in the comments field.
      Data Collection     Daily Nutrition
                                                                                                           If the patient is extubated and remains in the ICU, you must
                                                                                                           submit a PV for that day only. Indicate on the PL that re-
                                                                                                           insertion of the tube was not clinically indicated.
                                             If on the day of extubation the patient receives < 80% of the If the patient is extubated and discharged from the ICU on
                                             enteral supplements, do I need to submit a protocol violation the same day, you do not need to submit a PV.
      Data Collection   Protocol Violation   (PV)?

                                             I have a REDOXS patient who is no longer receiving study
                                             supplements because IV and GI access are no longer
                                             clinically required and orders have been written to discharge   You must enter the actual discharge date. Also, you need to
                                             the patient from ICU. The problem is that the patient needs     enter the available data components for the length of the
                                             to wait around in the ICU for a couple of days until a bed      study period; which in this case is until the patient is actually
                                             becomes available. Which date do I enter into the eCRF, the     discharged from the ICU. If this data is not entered you will
      Data Collection    Discharge Dates     discharge order date or the actual discharge date?              get an input warning.
                                             What temperature should I be collecting on the daily data       Record the patient’s temperature that is most aberrant from
      Data Collection      Daily Data        page?                                                           midline 37 C.
                                                                                                             Enter the date/time the patient was transferred from the
                                                                                                             acute care facility to the rehabilitation facility as the
                                                                                                             discharge date/time. If it is an internal transfer (e.g. the
                                             What hospital discharge date/time should I capture if the       rehabilitation facility is part of the hospital), please enter this
      Data Collection   Hospital Outcomes    patient is going to a rehabilitation facility?                  transfer date as the discharge date.

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                                                                      REDOXS FAQ Log
         Category            Sub Category                                    Question                                                   Response
                                                                                                              Yes. Remember that you are recording the location of the
                                                                                                              feeding tube (confirmed/presumed) rather than the type of
                                                                                                              feeding tube used. Record the location of the feeding tube
                                                  If patients are being fed via kaofeed, and the supplements according to the location of the tip of the tube. For example,
                                                  are infusing via NG/OG, do we record post pyloric (for      you may be using a small bowel feeding tube but the actual
                                                  example) for feeding tube in the CRF and then make a        location of the tip may be coiled in the stomach and hence
      Data Collection          Daily Data         comment that the supplements are infusing via NG (gastric)? the location should be recorded as gastric.
                                                                                                                  For NG drainage (to low gomco/drainage tube), please do
                                                                                                                  not record as gastric residual volumes. Gastric residual
                                                                                                                  volumes are recorded when you are actually aspirating and
      Data Collection          Daily Data       Do we record NG drainage as gastric residual volume?              checking to see how much residual is left in the stomach.
                                                In the collection of daily data, we are asked to indicate the
                                                worst PF ratio. If I have both non-ventilated and ventilated      You should capture the worst PF ratio, regardless of whether
      Data Collection         Daily Data        PF ratios, which one should I capture?                            the patient is ventilated or not.
                                                In the collection of concomitant medications, we are asked to
                                                collect insulin units per day. Do you want me to capture all      Yes, please record ANY kind of insulin (i.e. sub-q, drip/IV
      Data Collection   Concomitant Medications insulin received?                                                 (total).
                                                                                                                  The total volume of gastric residual volumes is equal to the
                                                                                                                  total volume measured regardless of whether you discard it
      Data Collection          Daily Data         How do I define gastric residual volume?                        or re-feed it.
                                                                                                                  If the antibiotic is started in ICU and continues after ICU
                                                                                                                  discharge, you will need to follow the patient to get this date.
                                                                                                                  When you enter this online, you will need to do the 3 (and 6)
                                                                                                                  month data manually and then enter it online later as you will
                                                  If an antibiotic is ongoing at ICU discharge, how should this   not be able to access outcomes until stop date of antibiotics
        EDC System             Antibiotics        be recorded in the EDC system?                                  has been entered.
                                                                                                                  Please interpret this as a blood sugar closest to 8am + 6 hrs.
                                                  Is there an acceptable range of time to collection the 8am      If there is no blood sugar available from 8am + 6 hrs, please
      Data Collection        Blood Sugars         blood sugar?                                                    choose n/a.
                                                                                                                  If the patient is still in ICU/hospital at 3 and/or 6 months, the
                                                                                                                  online version of the SF-36 will not appear on the Patient
                                                                                                                  Status page. In these cases, the research coordinator will
                                                                                                                  need to administer the survey manually and enter the data
                                                                                                                  into the eCRF retrospectively, once the discharge dates are
                                                  How do I enter the SF-36 responses if the patient is still in   entered. A hard copy of the SF-36 can be found in the
        EDC System               SF-36            hospital at 3, 6 months?                                        Implementation Manual (pg 87)

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                                                           REDOXS FAQ Log
         Category       Sub Category                             Question                                                         Response
                                                                                                      When you record all antibiotics started within the period of 7
                                                                                                      days prior to ICU admission, we are only referring to the
                                                                                                      current hospital stay before ICU admission, if applicable. We
                                       I have a patient who received antibiotics at home but within 7 are not asking you to collect data for other hospital stays that
                                       days of ICU admisssion, do I need to obtain this antibiotic    may have occurred shortly before the current stay or for
      Data Collection    Antibiotics   data?                                                          antibiotics use at home.
                                                                                                      Propofol kcalories are added to total energy for parenteral
                                                                                                      nutrition ONLY if the propofol is continuously infused for > 6
                                                                                                      hrs within your 24 hr flowsheet period (i.e. within a study
                                                                                                      day). If the propofol is infused for < 6 hours or is an
                                                                                                      intermittent dose the calories from propofol SHOULD NOT
                                                                                                      be included in PN Total Energy. If is not requried to
                                                                                                      seperately identify the propofol on the eCRF, but the site
                                                                                                      dietitian may want to keep record of the energy contribution
                                       A number of you have inquired about the contribution fo        from propofol on her daily work sheet in case a discrepancy
      Data Collection     Propofol     propofol calories to total energy.                             is found during source verification.
                                                                                                      If seizures occur in the ICU and the patient needs
                                                                                                      anticonvulsants and there is no documented history or
                                                                                                      seizures needing anticonvulsants prior to this illness, this
                                                                                                      patient is eligible. Patients with acute seizures requiring
                                       Are patients who have had an ACUTE seizure requiring           anticonvulsants are eligible yet patients with a history of
          Eligibility     Seizures     anticonvulsants eligible for the study?                        seizures requiring anticonvulsants are an exclusion.
                                                                                                      Once opened, the bag of parenteral study supplements is
                                                                                                      good for 24 hours only. You may change the IV tubing as
                                                                                                      per your hospital's standard protocol. This is done at varying
                                                                                                      frequencies depending on your institution (usually anywhere
                                       At what frequency should we change the IV tubing for           from 24-72 hours). For further detail, refer to the
    Study Supplements     IV tubing    parenteral study supplements?                                  Administration of Study Supplements Manual, page 8.
                                       When a patient is extubated, receiving parenteral nutrition    No need to calculate calories and protein from oral feeding.
                                       and eating a little bit, do we need to calculate the amount of We only need the calories and protein for parenteral and
          Nutrition     Oral Feeding   calories and proteins from oral feeding?                       enteral nutrition.

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                                                                      REDOXS FAQ Log
         Category            Sub Category                                   Question                                                    Response

                                                                                                               If a patient is discharged to the floor before the patient has
                                                                                                               received 5 days of study supplements, then study
                                                 We had a patient that was discharged from ICU to the floor    supplements would be continued on the floor to achieve the
                                                 after being on study supplements for 2 weeks. Our             5 days. Given this scenerio, since the patient has already
                                                 pharmacist was asking if study supplements could be           received 5 days of study supplements they should not be
                                                 continued on the floor as long as the site investigator was   given study supplements on the floor, the duration cannot be
    Study Supplements   After Discharge from ICU agreeable?                                                    extended at the discretion of the Site Investigator.
                                                                                                               We define mechanical ventilation as intubation with
                                                                                                               mechanical ventilation or tracheostomy with mechanical
                                                                                                               ventilation. This includes any positive pressure delivered via
                                                                                                               endotracheal tube or a tracheostomy. This does not refer to
                                                                                                               non-invasive methods of ventilation such as BiPAP or mask-
                                                                                                               CPAP unless non-invasive ventilation (e.g. BiPAP, CPAP) is
                                                  If a patient is extubated but on BiPAP, is this considered   delivered through a tracheostomy (if latter, then considered
          Eligibility             n/a             mechanical ventilation for the purpose of the study?         invasive mechanical ventilation.

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                     EDC System

                     Study Supplements


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                     Data Collection


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