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									                           Annexure – I
     RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

     PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.    Name of the candidate                DR.ABHISHEK SAINI
      and                                  K.D.J.S.SAINI HOSPITAL,
      Address                              NEAR KALI DEVI MANDIR ,HANSI(HISSAR)
                                           HARYANA-125033
2.    Name of the institution              MVJ MEDICAL COLLEGE AND RESEARCH
                                           HOSPITAL
3.    Course of study and subject          M.D. (GENERAL MEDICINE)
4.    Date of admission to course          01-06-2011
5.    Title of the Topic

        A CORRELATIVE STUDY OF CUFF HYPERTENSION AND
       ANTHROPOMETRIC VARIABLES IN OBESE AND NON OBESE
                          SUBJECTS.


6.    Brief resume of the intended work:

      6.1 Need for the study

                   Overweight and obesity represent a rapidly growing threat to the healthy
             populations in a number of countries and obese individuals tend to have a larger
             mid-arm circumference (mid-AC) than non obese individuals. Therefore, there is a
             need for caution in measuring blood pressure(BP) in the obese. Cuff characteristics,
             i.e, the cuff-bladder width and length, can bias measurement of blood pressure in
             the obese.
             Overestimation of blood pressure by using an inappropriately small cuff is well
             documented. Using a BP cuff small for mid-AC in obese patients results in higher
             BP readings than in the non obese patient . A bladder width that is too narrow for
             the mid -AC will tend to overestimate BP, called ‘cuff hypertension’. The most
             important adjustment for measuring blood pressure in the obese derives from
             choosing the correct cuff width-arm circumference (CW/AC) ratio. The
             recommendation is, that the cuff width should be at least 40% of AC i.e. a ratio of
             0.40. However for larger arm circumferences a ratio of 0.46 has been
             recommended.[1 ]
             The American Heart Association (AHA) in 2005 recommended four cuff sizes to
             cater for the varying ACs : [1]
                    A small adult cuff with a bladder measuring 10x24 cm for an arm
             circumference range of 22–26 cm,
                    An adult cuff with a bladder measuring 13x30 cm for an arm circumference
             range of 27–34 cm,
             A large adult cuff with a bladder measuring 16x36 cm for an arm
        circumference range of 35–44 cm,
    •        An adult thigh cuff with a bladder measuring 16x42 cm for arm
        circumferences between 45 and 52 cm.
        Others have recommend the use of a large adult cuff for AC greater than 33cms.


 The increasing prevalence of obesity and its associated conditions, such as hypertension,
accentuates the importance of the recognition of the relationship of an appropriate sized
cuff and accurate blood pressure measurement. The current recommendations by the
American Heart Association(AHA), European Society of Hypertension(ESH),British
Society of Hypertension(BSH) highlight the use of different cuff sizes for different ACs.
[2] There is no such provision for the adult Indian population. The latest API Guidelines
for Management of Hypertension in Indian Patients , 2007, advocates the use of a single
cuff 12x35 cms. [3]

         Therefore, there is a need to study the relationship between BP and arm
        circumference, so as to accurately estimate blood pressure in obese individuals, to
        avoid the problem of “cuff hypertension”.

.

    2   Review of literature



        In 2001 M Aylett et al did a study on “Evaluation of normal and large
        sphygmomanometer cuffs using the Omron 705CP (semi-automatic digital
        sphygmomanometer)”. 22 subjects of arm size greater than                28 cm in
        circumference were selected. Omron ‘normal’ and ‘large’ cuffs were used
        alternately, taking five blood pressures with each to a total of 30 readings per
        patient, resulting in 660 readings, 330 with each cuff.
               The results showed that:
               For all subjects the mean systolic/diastolic differences were of 2.7/3.8
        (p<0.001)
               When divided into two groups with systolic blood pressures below or above
        140 mm Hg, the mean systolic/diastolic differences were as significant (p<0.001)
        They recommend that large cuffs should be used for all patients with an arm
        circumference of 28 cm or above.[4]


        In a study done by Graves at the Mayo Clinic, the largest to address the issue of the
        distribution of blood pressure cuff sizes necessary to accurately measure blood
        pressure. The blood pressure was measured with a regular arm, large adult and
        thigh cuff in 470 patients - 350 patients with BMI less than 34 and 120 patients
        with BMI greater than 34.
       In the subjects with BMI less than 34, none of the cuffs misclassified the patient as
       having high blood pressure, borderline high blood pressure or normal blood
       pressure.
       In the subjects with BMI greater than 34, subjects were 2.2 times more like to be
       classified as hypertensive and 1.4 times more likely to be classified as borderline
       hypertensive when the standard arm cuff was used to measure blood pressure
       compared with when the classification was based on the more appropriately sized
       large adult or thigh cuff.
       He concluded that: the correlation of cuff size to body weight suggests that with
       the increasing prevalence worldwide of obesity, the use of large adult cuffs will be
       necessary.[5]

        In a study done by Guagnano et al, 1791 overweight or obese women,( 41-60
years), were divided into two subgroups. In the first one, causal BP was measured with a
standard-size cuff (RCS), while an appropriate large-size cuff was used for the second one
(LCS). Patients of the latter subgroup were also divided by type of obesity (android and
gynoid), based on their waist-to-hip ratio.
        They found that in the LCS subgroup, the hypertension prevalence rate was
        strikingly lower among overweight and obese women, as well as in the younger
        and older age groups, when compared with the corresponding RCS subgroups (p <
        0.001).
        The hypertension prevalence rate was higher for all android obese subjects (53%),
        including younger (34%) and older (64%) groups, when compared with gynoid
        obese patients (29%, 18% and 42%, respectively).
        They concluded that cuff hypertension and the prevalence of android obesity in the
        obese study population, could be responsible for over-estimating the prevalence of
        hypertension. [6]

       In 2011, Kanavi Roopa et al, did a collaborative study in Bangalore, Davangere
       and Salem, on 117 male obese subjects and 117 non-obese subjects to correlate
       body mass index and blood pressure.
       They found that there was a statistically significant increase in SBP in obese
       subjects compared to non-obese in all age groups. (P value < 0.001). They also
       found a positive correlation between BMI and systolic and diastolic blood
       pressure.[7]

        Zdrojewski et al did a study on the “Arm circumference in adults as an important
factor influencing the accuracy of blood pressure readings”. They      examined        a
representative sample of adults in Poland consisting of 3051 men and women aged 18-94
years
         They found that
            – In hypertensives              AC >32cms were 36% and <24cms 3%
            – In overweight/obese           AC> 32 cms were 40% and <24cms 0.6%
            – Mean AC in patients with Arterial hypertension was 30.4+/-3.9 cm and was
                significantly greater (P<0.01) than in normotensive subjects (28.4+/-3.7
                cm)
            They concluded that in patients with Arterial Hypertension or overweight and
            obese subjects, wider cuffs should be used in approximately 40% of subjects.[8]


            In 2003, Fonseca-Reyes et al, did a study on 120 subjects with an arm
            circumference greater than 33cm, 244 patients from a family health unit and 216
            patients from a hypertension clinic. They measured the effect on blood pressure
            readings when a standard cuff was used.
            They found that:
                – Overestimation of blood pressure when a standard cuff was used in obese
                    subjects
                – For every 5cm increase in arm circumference , a 2-5 mm hg increase in
                    systolic blood pressure and 1-3 cm increase in diastolic pressure was
                    observed.[9]



                  6.3 Objectives of the study

        •   To determine if cuff hypertension is present in obese subjects.


        •   To correlate BP with BMI, MAC, MAMC and Triceps skin fold thickness .




7.   Materials and Methods:

     7.1 Source of data
         •          A minimum 200 Obese and 200 Non Obese subjects between 20-50 years
            of age belonging to the community in and around Hoskote district, who come to
            IP/OPD in department of medicine, MVJMC&RH

     7.2 Method of collection of data :

        •   200 Obese and 200 non obese adults of both sexes
        •   Obesity is measured according to BMI
        •   Normal BMI :18.0-22.9 kg/m2, Overweight:23.0-24.9 kg/m2, obesity:>25
            kg/m2.(10).
        •   Anthropometric measurements:
                    Weight
               Height
               Mid-arm circumference
               Triceps skin fold thickness
               Waist circumference
               Hip circumference

   •   Calculation of BMI and Mid-arm muscle circumference.
   •   Systolic and diastolic blood pressure using a mercury sphygmomanometer and two
       cuff sizes
           – Standard cuff            12 cms width (for MAC <32cms)
           – Large cuff               15 cms width (for MAC >32cms)
   •   BP to be recorded using guidelines laid down by the Indian Hypertension
       Guidelines II.




        Inclusion criteria: 200 Obese and 200 Non obese individuals between 20-50
       years of age in and around Hoskote who come to IP/OPD in department of
       medicine, MVJMC&RH

          Obese subjects will be selected based on BMI.

       Exclusion criteria:

   •   Subjects on anti hypertensive medication
   •   Secondary causes of clinically identifiable hypertension
   •   Diabetic subjects who are known hypertensives or with complications of DM
   •   Pregnant women .
   •   Known cases of Ischemic heart disease.

7.3 Does the study require any investigations or interventions to be conducted in patients
or other humans or animals? if so, please describe briefly

   NO.




7.4 Has ethical clearance been obtained from your institution in case of 7.3?

                              Yes
8.   List of references


        1. Response to Recommendations for Blood Pressure Measurement in Human and
            Experimental Animals; Part 1: Blood Pressure Measurement in Humans and
            Miscuffing: A Problem With New Guidelines: Addendum Hypertension.
            2006;48:e5-e6,
        2. Paolo Palatinia and Gianfranco Paratib, Blood pressure measurement in very obese
            patients: a challenging problem Journal of Hypertension 2011, 29:425–429.
        3. Indian Hypertension Guidelines II. (2007)
            http://www.apiindia.org/hypertensionguidelines/hyperhome.htm
        4. M Aylett1, G Marples1, K Jones1 and D Rhodes Evaluation of normal and large
            sphygmomanometer cuffs using the Omron 705CP Journal of Human
            Hypertension (2001) 15, 131–134
        5. Graves, W. John . Prevalance of blood pressure cuff sizes in a referral practice of
            430 consecutive adult hypertensives. Blood pressure Monitoring: February 2001-
            volume 6-issue 1-pp 17-20.
        6. Guagnano MT, Palitti VP, Murri R, Marchione L, Merlitti D, Sensi S. Many factors
            can affect the prevalence of hypertension in obese patients: role of cuff size and
            type of obesity Panminerva Med. 1998 Mar;40(1):22-7( abstract)
        7. Kanavi Roopa Shekharappa , Smilee Johncy S , Mallikarjuna P T , Vedavathi K J ,
            Mary Prem Jayarajan. Correlation between body mass index and cardiovascular
            parameters in obese and non obese in different age groups . International journal of
            Biological & Medical Research.2011;2(2):551-55
        8. Zdrojewski T, Kozicka-Kakol K, Chwojnicki K, Szpakowski P, Konarski R,
            Wyrzykowski B. Arm circumference in adults in Poland as an important factor
            influencing the accuracy of blood pressure readings. Blood Press Monit. 2005
            Apr;10(2):73-7.
        9. Reyes- Fonseca, C Salvadora, de Alba- Garcia et al.Effect of standard cuff on blood
            pressure readings in patients with obese arms. How frequent are arms of a large
            circumference. Blood Press Monitoring: 2003 Jun;8(3):101-6 (abstract)
        10. A Mishra,P Chowbey,BM Makkar,NK Vikram et al.Consensus statement for
            diagnosis of obesity,abdominal obesity and the metabolic syndrome for asian
            Indians and recommendations for physical activity,medical and surgical
            management.JAPI.57:163-170.

9.   Signature of Candidate :
10 Remarks of the Guide:
   This study on ‘’Cuff Hypertension’’ presence in obesity is likely to reduce the burden of
   hypertension in obese patients.




11 Name & Designation of
   11.1 Guide
          PROFESSOR DR AJOY.KRISHNAMURTHY
          MD(GENERAL MEDICINE)
          PROFESSOR OF MEDICINE

     11.2 Signature



     11.3 Co-Guide



     11.4 Signature



     11.5 Head of Department
             DR.P CHANDRASEKHARA
             MD (GENERAL MEDICINE)
             PROFESSOR OF MEDICINE
             HEAD OF THE DEPARTMENT
     11.6 Signature




12
     2.1 Remarks of the Chairman And Principal
12.2 Signature

								
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