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Caroline Whaley _deceased_

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Caroline Whaley _deceased_ Powered By Docstoc
					Report under Rule 43 Coroners’ Rules 1984
C (deceased)
[Amended to anomymise child and others]




The Facts
C died on the 22nd December 2002 aged 8. Although suffering a number of medical
problems including cerebral palsy and scoliosis, C had a good quality of life and a 93%
attendance at school.
C suffered recurrent bouts of pneumonia from 2000 but recovered after each one. She
had admissions for chest infections in July and October 2002. On the 3rd December
2002 C suffered a chest infection that her family recognised as far worse than previous
occasions, she was taken to a Children’s Hospital (the hospital) where she was
admitted. By the following day she was transferred to the Paediatric Intensive Care Unit
where it was initially thought that she may not survive. However, C’s condition improved
overnight to the extent that notes on the 5th December reported her as “much brighter,
eyes open, sitting up”. It was not suggested by any witness that C was bound to die at
that stage regardless of what followed.
Around lunchtime on the 5th December Staff Nurse M was asked to place a nasogastric
tube so that C could start to take some feed. Staff Nurse M was an experienced nurse
who had carried out this procedure on many occasions. Earlier in the year she had been
asked to write guidance on this procedure for the new nurses Induction Pack and her
work was authorised for inclusion by the Clinical Nurse Educator.
The placing of the tube was apparently without incident. Some relatives present felt that
C showed signs of distress but the nurses thought that C had shown less resistance to
this unpleasant procedure than many children. However, it now seems clear that the
tube did not go down the oesophagus and into the stomach as intended but went
through the left lung and into the pleural space.
Having placed the tube, Staff Nurse M followed what she described as the standard
practice to check correct placement of the tube. Although there was no written
guidelines in place (beyond Staff Nurse M’s own work for new nurses) the hospital
accepted that Staff Nurse M had followed well recognised procedure. This consisted of
one of the following:
   Using a small syringe to aspirate some fluid from the nasogastric tube, which was
    then tested on blue litmus paper. The principle was that if the tube was correctly
    placed in the stomach the aspirated contents would be acid and would therefore turn
    the blue litmus paper pink.
   The so called “whoosh test” which involves using the syringe to push a small volume
    of air down the nasogastric tube whilst listening to the stomach with a stethoscope.
    In theory, if air is heard to be expelled it is likely that the tube is within the stomach.
   An x-ray. Obviously there is resistance to frequent x-rays for a child, particularly
    bearing in mind that some children can remove a nasogastric tube repeatedly.
On this occasion Staff Nurse M could not draw any aspirate, which was said to be a
common situation when a child has not received food for some time. Consequently she
moved to the whoosh test. The test was initially performed by Staff Nurse M who
considered it satisfactory. However, her colleague Staff Nurse L had been present for
placement of the tube and was said to have listened herself whilst the whoosh test was
repeated. Again the result was considered satisfactory. Feeding was commenced at
10mls per hour.
An hour later Staff Nurse M performed the aspirate test again. She was reassured that
the small amount of aspirate drawn off turned the blue litmus paper pink thus showing
acidity. If the test had not given this result it would have caused sufficient concern to
stop the feed and an x-ray would likely have taken place. Had the error been discovered
at that point, when only 10mls of food had been given, it is considered unlikely that C
would have died as a consequence. Unfortunately that was not the case and the feed
continued at 10mls per hour.
During the subsequent (night) shift Staff Nurse H was responsible for C’s’ care, she told
the inquest that prior to increasing feed to 20mls per hour she had also performed the
aspirate test with blue litmus paper turning pink. C’s condition was deteriorating through
this shift but that was initially thought to be as the result of a physio session undertaken
during the evening. However C’s oxygen levels continued to fall and an x-ray was the
first indication of the true position. C had received 360mls of feed by then.
All of C’s problems in 2002, prior to this admission, had been in the left lung. The
December 2002 admission concerned problems in C’s right lung. The nasogastric tube
went into the left pleural space.
Over the following days C became very ill indeed and by the 19th December it was
agreed that treatment should be withdrawn so that she could die peacefully. She died at
her home on the 22nd December 2002.
The pathologist confirmed that the cause of a death arose as a consequence of the
misplaced tube.


The Placement Checks
The inquest looked in some detail at the issues surrounding the two placement checks
used in this case. Evidence was given by an experienced nutrition nurse from a different
area. It became apparent that the two placement checks used had failed for entirely
separate reasons that were already known in some areas of the country.
The whoosh test had been called into question in various research literature during the
1990’s. It seems to have been recognised in a number of places, perhaps because of
individual incidents occurring there, that this test was far from infallible. There are at
least two reasons for this. Firstly, there is a considerable possibility of referred sound, in
any event with a small child the placement of a tube in the pleural cavity will only be two
or three inches distant from where the tube might be expected in the stomach.
Secondly, the test by its very nature is fragile because few nurses will have had the
opportunity to hear the distinction in sound arising from an incorrectly placed tube.
The litmus paper test has been used widely for some considerable time. For some
months after the death staff at the hospital were at a loss to explain why a tube placed
into the pleural space had provided a falsely reassuring acid reaction. The food is
manufactured to a strict standard with a broadly neutral pH that should not affect litmus
paper. However, in August 2003 (shortly before the inquest was first listed to be heard)
a casual experiment by curious staff at the hospital showed that feed did turn the litmus
paper pink. This revelation was followed by a more considered study (although still
under ward rather than laboratory conditions) in which a wide range of feeds were tested
on litmus and pH paper. This suggested that whilst most of the feeds showed a broadly
neutral reaction on pH paper (with a pH of about 8) many turned blue litmus paper pink
to a greater or lesser degree. These claims, which I found no reason to doubt, seemed
to be backed up by a 2003 paper by Jamil Khair (who the court was aware is a nutrition
nurse) which showed that some blue litmus paper in the NHS registers at a pH of 5 to 8
giving the possibility of a colour change at a neutral 7. In short, if the aspirate drawn off
is feed there is a prospect that this could be mistaken on the litmus test for acid stomach
content and false reassurance taken.
The feed manufacturers in this particular case had checked the pH on samples of the
batches sent to the hospital at the appropriate period and found them to be satisfactory.
A test of the feed using blue litmus paper in court did not provoke the reaction to pink,
leaving a strong inference that not all litmus papers are the same.
Finally, it is relevant to make some comment with regard to the Royal Marsden Hospital
Manual of Clinical Nursing Procedures which is widely recognised as an authoritive and
perhaps definitive guide to appropriate nursing practice. In writing her own guide for
new nurses in early 2002 Staff Nurse M was not aware of a revision of the Manual
published in 2001. Her practice, clearly reflecting hospital practice, was consistent with
the 4th edition of the Manual which made reference to the whoosh test and the use of
litmus paper.
The 5th edition of Marsden in 2001 changed guidance by advocating use of one of the
following;
   Aspirate stomach contents and use pH indicator strips, waiting an hour after feed or
    medication and flushing the tube with air to clear substances.
   Checking for the sound of air in a manner similar to the whoosh test but the manual
    talks of a bubbling sound. It is not clear to me whether the manual is intending some
    subtle change from the whoosh test by use of this phrase but if so, this was clearly
    lost on the experienced nursing and medical staff who gave evidence at my inquest.
    They regarded this as a description of the whoosh test without using the name.
   An x-ray check.


Comparisons
Incorrect placement of a nasogastric tube, for whatever reason, is a well recognised
complication, although in less than one percent of adults and probably rather less than
that in children. However, where a tube was incorrectly placed literature suggests that
perforation of the lung will occur in something approaching half of cases. There is
therefore a significant danger in failure to recognise an incorrectly placed tube,
particularly as the patient requiring a nasogastric tube is likely to be compromised in
some way by whatever has caused the need for feeding in the first place. Children with
cerebral palsy may have an inhibited gag reflex leading to an arguably higher risk of
incorrect placement yet are also subject to recurrent chest infections as in C’s case.
As a result of their own findings, the hospital carried out an informal survey of 24
Paediatric Intensive Care Units in November 2003. At that time 14 hospitals out of the
24 used the whoosh test as an acceptable test. Seven more used it as an adjunct.
Further, 17 used litmus paper to check acidity in a placement test and only 4 used pH
paper, two used both. This strongly suggests that only six months ago the failure of
tests that befell C would still happen in more than half the Paediatric Intensive Care
Units in the country.
There is currently no requirement for a feed manufacturer to include the pH value of the
feed on the packaging. Consequently any nurse checking for a reaction, even using pH
paper, is working by assumption rather than the distinct knowledge that any pH paper
showing a value of less than six is a cause for concern (the acceptable range on this
particular feed if 6.5 – 6.9).
By coincidence, the feed manufacturers in this particular case also manufacture
nasogastric tubes which contain pictorial instructions requiring a placement check giving
a pH of less than four. This plainly infers the use of pH rather than litmus paper.
Unfortunately, not all manufacturers follow this practice and the tube used in C’s case
was made by another company who did not include any instructions on their packaging.
Finally, it is of interest to note that the Medicines and Health Care Regulatory Agency
(MHRA) have never had an incident of a misplaced nasogastric tube reported to them
prior to the death of C. Yet the MHRA would consider reporting of such incidents to be
important, including the opportunity to examine the nasogastric tube (and presumably its
packaging). Whilst it may always be assumed that misplacement is due to other factors
it is only by examination of the tube that a product fault can be discounted.


Summary
It is apparent that unless some clear action is taken immediately to highlight the lessons
learnt at the hospital from the death of C, the possibility remains of the events being
repeated elsewhere. I believe I am right in saying that the hospital and the family join
with me in urging immediate consideration of the following.
1. That the Department of Health should issue an immediate alert to all hospitals
   cautioning against use of the whoosh test as a primary check for placement of
   nasogastric tubes and requiring such practice to cease immediately.
2. That the Department of Health issue an immediate alert on the risks of using blue
   litmus paper in checking for aspiration of gastric contents and requiring that pH paper
   be introduced as soon as reasonably practicable into the clinical setting. It is
   recognised that the transition is not entirely straight forward and may take some time
   to achieve.
3. It is understood that the National Nutrition Nurses Group are to issue some national
   guidelines on this topic later in the year. However, if distribution of these guidelines
   is restricted to the Group not all hospitals may receive the benefit of this advice as
   not all have a nutrition nurse. It is suggested that if the guidelines are considered
   appropriate and are reflective of the issues revealed in this case (and it is strongly
   anticipated that they will be) the document should be widely promulgated and could
   perhaps be taken forward through the National Institute for Clinical Excellence.
4. Whilst it is appreciated that the current edition of the Royal Marsden Manual may
   shortly be replaced, it is suggested that an immediate alert is issued by the
   Department of Health clarifying the wording used and in particular whether checking
   for a bubbling sound is to be regarded for practical purposes as equivalent to the
   whoosh test (and if so to cease forthwith). Clarification might also be given on the
   reference to waiting for an hour before using litmus paper.
5. Feed manufacturers should be required to show the pH of their product on the
   packaging so that comparison with pH results is practicable.
6. Nasogastric tube manufacturers should be required to include appropriate
   instructions on their packaging including acceptable placement checks.
7. The Department of Health, the National Institute for Clinical Excellence and the
   National Patients Safety Agency should consider a scheme for national promulgation
   of adverse incidents in appropriate circumstances.
8. Hospitals should be specifically advised that the misplacement of naso-gastric tubes
   should be reported as an incident to the Medicines and Health Care Products
   Regulatory Agency so that the incidence can be monitored nationally.




(signed)
HM Coroner
27.04.04