Bombay Hospital, Maharashtra

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. Name of the Institution Bombay Hospital, Maharashtra

2. Date of Submission ​28-09-2018

3. Title of the Topic ​INVESTIGATIONAL STUDY OF RESPAP

KIT FOR BUBBLE CPAP OXYGEN
THERAPY IN CHILDREN UNDER FIVE
YEARS OF AGE

4. Authors Dr. Mallesh Kariyappa

Gautham Pasupuleti

Dr. Sarala Sabapathy

Roshan Mohan
1. Brief resume of the intended work

1.1 Need for the study

In developing countries, mortality in children with very severe pneumonia is high,
even with the provision of appropriate antibiotics, standard oxygen therapy, and
other supportive care. In 2010, an estimated 120 million episodes of pneumonia in
children younger than 5 years old, and 14 million cases progressed to severe
pneumonia, as defined by World Health Organisation (WHO).​1 In 2011, an
estimated 1·3 million children died from pneumonia. Hypoxaemia is a major risk
factor for death in children with pneumonia and effective management of severe
pneumonia and hypoxaemia is a major challenge for clinicians in developing
countries.​2,3,4 In addition to antibiotics and supportive care, WHO recommends
oxygen supplementation if the arterial oxygen saturation measured by pulse
oximetry (SpO2) is less than 90%, or if a child has cyanosis, is unable to feed, or
shows other danger signs.​5 WHO recommends giving oxygen by nasal cannula at
the following flow rates: 0·5–1 L/min for neonates, 1–2 L/min for infants and
children younger than 2 years, and 2–4 L/min for children 2 years and older,​5 and
improving oxygen therapy has been shown to reduce mortality from severe
pneumonia in developing countries.​6 However, despite the provision of oxygen,
antibiotics, and supportive care, case-fatality rates for severe pneumonia and
hypoxaemia are high in many hospitals in developing countries (5–15% in
observational studies).​7–14
WHO in its guidelines for oxygen therapy​15 recommends the use of an
inexpensive bubble CPAP setup with modified nasal prongs. This involves cutting
normal nasal prongs and submerging one end of it in a calibrated water chamber.
This frugal method is skill intensive and unstandardised.
To address this issue- Biodesign Innovation Labs has developed a low-cost a
CPAP circuit. The circuit generates pressure from the oxygen cylinder connected
at one end and maintains the PEEP (Positive End Expiratory Pressure) with the
help of a bubbling chamber, filled with sterile water.

The main aims/uses of the kit are as follows:

1. To serve as an intermediate solution between tertiary care devices and a
frugal un-standardized setups.
2. To provide oxygen therapy in tertiary and secondary care units during an
emergency.
 Hence, the proposal to conduct a study to compare the efficacy of (a) ResPAP Kit
with that of (b) the standard O2 supplementation by nasal prongs in the
management of hypoxic children.

1.2 Objectives of the Study:

1. To evaluate the efficacy of ResPAP Kit compared to Standard Nasal

Oxygen.
2. Assess the safety of the device with respect to mortality and morbidity.

2 Review of Literature

Mohammod J Chisti et al (16) conducted open, randomised, controlled trial,

assigned 225 eligible children younger than 5 years with severe pneumonia and
hypoxaemia to receive oxygen therapy by either bubble CPAP, standard low-flow
nasal cannula (2 L/min), or high-flow nasal cannula (2 L/kg per min up to the
maximum of 12 L/min). Concluded that significantly fewer children in the bubble
CPAP group had treatment failure than in the low-flow oxygen therapy group. No
difference in treatment failure was noted between patients in the bubble CPAP
and those in the high-flow oxygen therapy group (RR 0·50, 99·7% 0·11–2·29;
p=0·175). 23 (10%) children died. Three (4%) children died in the bubble CPAP
group, ten (15%) children died in the low-flow oxygen therapy group, and ten
(13%) children died in the high-flow oxygen therapy group. Children who
received oxygen by bubble CPAP had significantly lower rates of death than the
children who received oxygen by low-flow oxygen therapy.

Wilson PT et al (17) conducted a randomized, controlled trial enrolling 70

subjects between 3 months to 5 years of age and concluded that CPAP decreases
respiratory rate in children with respiratory distress compared with children not
receiving CPAP. The technology was successfully used by local nurses and no
complications were associated with its use.
3 Materials and Methods:

Source of Data:
Data obtained from babies admitted to Bombay Hospital, Maharashtra, during the
study period will be considered for this study.

Method of Collection of the Data:

Pretested guidelines will be used to collect the data set of with ResPAP kit and
standard low flow oxygen therapy. The relevant life quality domain will be
considered for the assessment of efficacy of the device with positive and negative
response rate collected during the study period.

The following parameters will be recorded at first contact or the time of admission
and at regular intervals as per WHO guidelines and institutional policies. This will
be considered for the assessment of the study, for efficacy.
1. Respiratory rate
2. Heart Rate
3. Retractions
4. Grunting
5. Nasal flaring
6. Pulse Rate, Pulse volume.
7. Level of consciousness/Glasgow Coma Scale (GCS)
8. Saturation
9. Arterial Blood Gas Analysis (ABGA)
10. Pressure in CPAP device
11. Complete Blood Count (CBC)
12. Serum Electrolyte.
13. Blood C/S

Investigations are done as demanded by the guidelines for management. The safety
of the device has been assessed by the morbidity and mortality of the patients. If the
mortality happens to be during the study period, we try to document accurate cause
of death and correlate all the selected parameters.
A. DESIGN OF STUDY
Hospital based observational prospective study.

B. PLACE OF STUDY
Bombay Hospital, Maharashtra.

C. SAMPLE SIZE

Children of either sex, aged between 6-59 months admitted in the pediatric unit of
Bombay Hospital, Maharashtra will be considered for the study.

Total number of subjects considered for study will be not more than 30.

D. INCLUSION CRITERIA (Annexure III)

1. Parents of babies included in the study willing to give written informed consent

2. Children of either sex, aged between 6-59 months, with hypoxaemia (SpO2 <
90%), Moderate to Severe pneumonia.

E. EXCLUSION CRITERIA

1. Parents of babies included in the study not willing to give written informed
consent

2. Hypercapnia (PCO2 > 60 mm of Hg), status asthmaticus and upper-airway

obstruction, Children with features (any two of three criteria given below) of
“clinical failure” (before enrolment into the study), needing higher level of
respiratory support at admission will also be excluded from the study.

3. Significant congenital malformations, and an age of >6 years are also treated as
the exclusion criteria.
F. METHODOLOGY

Informed consent will be taken from the parents of study subjects (Annexure I). As
soon as the baby is admitted to Bombay Hospital, Maharashtra,,. the details will be
entered in a predesigned proforma. (Annexure-II) This includes all hematological
parameters, respiratory rate, heart rate, retractions, grunting, nasal flaring, pulse
rate, cyanosis, level of consciousness, saturation, pH. The examination findings
including vitals and anthropometry will be recorded. Patients are randomised into
the normal nasal oxygen group (Group: 1) and the ResPAP kit group(Group: 2).
Patients in the first group will be administered normal nasal oxygen using standard
mode of care present and will be observed for improvement. Patients enrolled to
second group will be provided oxygen therapy using ResPAP kit with a Positive
End Expiratory Pressure PEEP valve

During the course of administration of normal nasal oxygen therapy, the patients
deteriorating in parameters such as the saturation level, sensorium level and heart
rate are switched to ResPAP kit, and if further deterioration occurs, the treatment is
abandoned and switched over to intubated ventilation or treatment as by the
protocol of the institution. Efficacy of the mode of oxygen delivery is evaluated
using the x​2 ​ chart.

G. ASSESSMENT TOOLS

1.Case Reporting Proforma(Annexure II)

2.Inclusion Criteria(Annexure III)

H. STATISTICAL ANALYSIS

Data will be entered in Microsoft excel and will be exported into SPSS version
211.0. Data will be analysed by descriptive statistics for statistical association
between variables.

Secondary data will be analysed by using SPSS -16.50 version, Univariate –logistic
regression will be employed to know the significance level. The ROC curve
analysis will be used to know the accuracy of the device.
List of References
1. Walker CL, Rudan I, Liu L, et al. Global burden of childhood pneumonia and
diarrhoea. Lancet 2013; 381: 1405–16.
2. Subhi R, Adamson M, Campbell H, et al. The prevalence of hypoxaemia among
ill children in developing countries. Lancet Infect Dis 2009; 9: 219–27.
3. Duke T, Frank D, Mgone J. Hypoxaemia in children with severe pneumonia in
Papua New Guinea. Int J TB Lung Dis 2000; 5: 511–19.
4. Graham SM, English M, Hazir T, Enarson P, Duke T. Challenges to improving
case management of childhood pneumonia at health facilities in
resource-limited settings. Bull World Health Organ 2008; 86: 349–55.
5. WHO. Hospital care for children: guidelines for the management of common
illnesses with limited resources, 2nd edn. Geneva: World Health Organization,
2013.
6. Duke T, Wandi F, Jonathan M, et al. Improved oxygen systems for childhood
pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet
2008; 372: 1328–33.
7. Shann F, Barker J, Poore P. Chloramphenicol alone verses chloramphenicol
plus penicillin for severe pneumonia in children. Lancet 1985; 2: 684–86.
8. Mishra S, Kumar H, Anand VK, Patwari AK, Sharma D. ARI control
programme: results in hospitalized children. J Trop Pediatr 1993; 39: 288–92.
9. Bahl R, Mishra S, Sharma D, Singhal A, Kumari S. A bacteriological study in
hospitalised children with pneumonia. Ann Trop Paediatr 1995; 15: 173–77.
10. Sehgal V, Sethi GR, Sachdev HP, Satyanarayana L. Predictors of mortality in
subjects hospitalised with acute lower respiratory tract infections. Indian Pediatr
1997; 34: 213–19.
11. Banejeh SM, al-Sunbali NN, al-Sanahani SH. Clinical characteristics and
outcome of children aged under 5 years hospitalised with severe pneumonia in
Yemen. Ann Trop Paediatr 1997; 17: 321–26.
12. Smyth A, Tong CY, Carty H, Hart CA. Impact of HIV on mortality from acute
lower respiratory tract infection in rural Zambia. Arch Dis Child 1997; 77:
227–30.
13. Duke T, Poka H, Frank D, Michael A, Mgone J, Wal T. Chloramphenicol
versus benzylpenicillin and gentamicin for the treatment of severe pneumonia in
children in Papua New Guinea: a randomised trial. Lancet 2002; 359: 474–80.
14. Tiewsoh K, Lodha R, Pandey RM, Broor S, Kalaivani M, Kabra SK. Factors
determining the outcome of children hospitalized with severe pneumonia. BMC
Pediatr 2009; 9: 15
15. Chapter 5, Continuous positive airway pressure, Oxygen therapy for children: a
manual for health workers; WHO 2016; 34-8.
16. Mohammod J Chisti, Mohammed A Salam, Jonathan H Smith, Tahmeed
Ahmed, Mark A C Pietroni, K M Shahunja, Abu S M S B Shahid, Abu S G
Faruque, Hasan Ashraf, Pradip K Bardhan, Sharifuzzaman, Stephen M Graham,
Trevor Duke. Bubble continuous positive airway pressure for children with
severe pneumonia and hypoxaemia in Bangladesh: an open, randomised
controlled trial. Lancet 2015; 386: 1057–1065
17. Wilson PT, Morris MC, Biagas KV, Otupiri E, Moresky RT. A randomised
clinical trial evaluating nasal continuous positive airway pressure for acute
respiratory distress in a developing country. J Pediatr 2013; 162: 988–92.
 ANNEXURE- Ia

INFORMED CONSENT

​ I have been explained, in a language understood by me about the study entitled

“​​ ​CLINICAL INVESTIGATIONAL STUDY OF ResPAP KIT FOR B-CPAP
OXYGEN THERAPY IN CHILDREN UNDER FIVE YEARS OF AGE”. ​conducted
under the guidance of Doctor.

I have been explained about the procedures and investigations that will be done during this
study. I have no objections to sharing my child’s medical information and details in case
records with the investigators of this study. Personal identity will not be revealed but data
may be used for publication / dissertation purpose.

I understand that my participation in this study is entirely voluntary and I am willing to

take part in this study.

Signature of the Doctor: Signature of the parent:

Name of the Doctor: Name of the parent:

Place: Name of the subject​:

Date:

Time:
 ANNEXURE- Ib

ಒ ಪತ
ಾಂಕ:____________

ೕ/ ೕಮ /ಕು ಾರ/ಕು ಾ __________________________________ ಆದ ಾನು, ಈ ಳ ಕಂಡ

ೖದ ೕಯ ಸಂ ೂೕಧ “ ​CLINICAL INVESTIGATIONAL STUDY OF ResPAP KIT FOR
B-CPAP OXYGEN THERAPY IN CHILDREN UNDER FIVE YEARS OF AGE.​​”
ಒಳಪಡಲು ನನ ‘ಸಂಪ ಣ ಸೂ ತ ಒ ’ ೕ ರು ೕ .

ಈ ಸಂ ೂೕಧ ಯ ಾಗವ ಸಲು ನನ ಸಂಪ ಣ ಒ ಇದು , ಇದರ ೕ ೕ ೕಶಗಳು,

ಉಪ ೕಗಗಳು, ಸಂಭ ಸಬಹು ಾದ ಅಡ ಪ ಾಮಗಳು ಾಗು ೕವ ಯ ಬ ನನ ಅಥ ಾಗುವ
ಾ ಯ ವ ರು ಾ .

ಇದ ಸಂಬಂ ದಂ ನನ ಆ ೂೕಗ ಾವ ೕ ೂಂದ ಾದ ೕಲ ಂಡ ೖದ ರು/ಸಂ ಯನು

ದೂ ಸುವ ಲ ಂದು ಯಪ ಸು ೕ .

ಈ ಸಂ ೂೕಧ ಯ ಾವ ೕ ಹಂತದ ಾನು ೂರನ ಯಬಹು ಾ ಎಂದು ನನ ಸ ಾ .

ೂೕ ಯ ಸ ಎಡ ನ ಗುರುತು

ಸಂ ೂೕಧಕರ ಸ ಾ ಾರರ ಸ
 ANNEXURE- Ic

सहम त प

अ ययन शीषक: ​“ ​CLINICAL INVESTIGATIONAL STUDY OF ResPAP KIT FOR

B-CPAP OXYGEN THERAPY IN CHILDREN UNDER FIVE YEARS OF AGE.​​”

तभागी का पण
ू नाम:______________________________________________

1. म​ ेर प
​ िु ट ह​ ै​कम​ ने अ
​ ययन ह ​ े तु स
​ च ू ना प​ क ​ ो ​पढ़ व ​ ​समझ ​ लया ह​ ैत​ था म
​ झु ेअ
​ ययन अ ​ वेशक
ने ​सभी ​त य क ​ ोस ​ मझा ​ दया ​है त
​ था ​मझ ु े ​ शन प
​ छ
ू ने क
​ े स
​ मान अ
​ वसर ​ दान ​ कये ग
​ ए ह
​ ै |

2. म
​ ने ​यह स ​ मझ ​ लया ​है क ​अ ययन म ​ ​मेर भ​ ागीदार प​ ण
ू तः ​ वैि छक ह ​ ै ​और ​म ​ कसी भ
​ ीस​ मय
कसी ​भी क ​ ारण क
​ े ​ बना, म
​ ेरे इ
​ लाज ​या क
​ ानन
ू ीअ​ धकार क ​ ो ​ भा वत ​ कये ​ बना, अ​ ययन म ​ भ​ ाग न
​
लेने ​के ​ लए ​ वतं ह ​ ू ँ|

3. म
​ ने ​यह स ​ मझ ​ लया ​है ​ क ​अ ययन क ​ े ​ ायोजक, ​ ायोजक क ​ त ​ रफ स ​ ेक​ ाम क ​ रने ​वाले ल​ ोग,
आचार ​स म त औ ​ र ​ नयामक अ ​ धका रय ​को म ​ ेरे ​ वा य ​ रकॉड क ​ ोव ​ तमान अ ​ ययन य ​ ाआ
​ गे ​के
अ ययन क ​ े स ​ दभ द ​ े खने क ​ े ​ लए ​मेर अ
​ नम ु तक ​ ज ​ रत न ​ हंह
​ ै , ​चाहे म​ ने इ
​ सअ ​ ययन ​से अ ​ पना
नाम ​वापस ल ​ े ​ लया ह ​ ो| ​हालां क,​म ​यह स ​ मझता ह ​ ूँ ​ क म
​ ेर ​पहचान क ​ ो ​ कसी भ ​ ी त
​ ीसरे प​ य
​ ा
का शत ​मा यम म ​ ​नह ं द ​ ज ​ ायेगी|

4. म
​ ​इस ​से स
​ हमत ह ​ ूँ ​ क क
​ ोई भ​ ीड
​ ट
े ाय
​ ाप​ रणाम ज ​ ो ​इस अ
​ ययन ​से ​ ा त ह ​ ोता ह
​ ैउ
​ सका ​वै ा नक
उ दे य(​ओ)​ं के ​उपयोग ​के ​ लए म ​ ेर ​तरफ स​ े ​कोई ​ तब ध न ​ हंह
​ ै |​म उ
​ परो त अ
​ ययन म ​ भ
​ ाग ल
​ ेने क
​ े
लए ​सहमत ह ​ ू ँ|

अ वेषक क ​ े ह
​ ता र- तभागी क
​ े ​ह ता र (​याअंगूठेका नशान)
गवाह ​के ​ह ता र-
 ANNEXURE II
CASE REPORTING PROFORMA

BABY NAME

SEX

BIRTH WEIGHT

FATHER NAME

ADDRESS

CONTACT NO

D.O.B

D.O.A

DIAGNOSIS

FEVER

COUGH

CORYZA

SORE THROAT

MALAISE

NOISY BREATHING/GRUNTING

CHEST INDRAWING

LOSS OF CONSCIOUSNESS

OTHERS
 ANNEXURE III
INCLUSION CRITERIA

Children of either sex, aged between 6-59 months, with hypoxaemia (SpO2 < 90%), Moderate
to Severe pneumonia as per guidelines of the Integrated Management of Childhood Illness
(IMCI) and the World Health Organisation (WHO).