| CTRI Number |
CTRI/2021/08/035409 [Registered on: 04/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bubble Continuous Positive Airway Pressure Oxygen Therapy in Children u with Pneumonia |
|
Scientific Title of Study
|
Bubble Continuous Positive Airway Pressure Oxygen Therapy (Biodesign Innovation Labs’s RESPAP KIT )in Children under Five Years of Age with Pneumonia in Pediatric Intensive Care Unit (PICU)-A Pilot study |
| Trial Acronym |
B-CPAP |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalitha AV |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital Bangalore |
| Address |
Pediatric Intensive Care Unit
Department of Pediatrics
St Johns Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560036
India |
| Phone |
9448461673 |
| Fax |
|
| Email |
drlalitha03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lalitha AV |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital Bangalore |
| Address |
Pediatric Intensive Care Unit
Department of Pediatrics
St Johns Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560036
India |
| Phone |
9448461673 |
| Fax |
|
| Email |
drlalitha03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lalitha AV |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital Bangalore |
| Address |
Pediatric Intensive Care Unit
Department of Pediatrics
St Johns Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560036
India |
| Phone |
9448461673 |
| Fax |
|
| Email |
drlalitha03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biodesign Innovation Labss RESPAP KIT
2nd Main,
No. 57/65, C.L.Layout, Hosur Main Road, DRC Post, Bengaluru, (Bengaluru) Urban, Karnataka, 560029 |
|
|
Primary Sponsor
|
| Name |
Biodesign Innovation Labss RESPAP KIT |
| Address |
Bangalore |
| Type of Sponsor |
Other [Biodesign Innovation Labs’s RESPAP KIT] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lalitha |
PICU,St Johns Hospital, |
Room Number:3151,3152,3153,3154,3155
Department of Pediatric Intensive care
St Johns Medical College Hospital
Sarjapur road,Bengaluru-560034
Bangalore
KARNATAKA |
9448461673
drlalitha03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J159||Unspecified bacterial pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Flow nasal cannula |
The HFNC system (Fisher & Paykel Healthcare
Airvo 2) used , comprised of a humidifier (MR290) and a continuous flow circuit (900PT531 for
infants, 900PT501 for Children). We selected the nasal prong size that best fitted the nostrils
(Optiflow, OPT318, OPT842, OPT844, OPT846), about half that of the nostril in order to allow
for leakage and avoid overpressure phenomena. The flow was adjusted to minimize the patient’s
clinical work of breathing |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
1)Children aged 5-59 months with diagnosis of pneumonia with mild to moderate respiratory distress |
|
| ExclusionCriteria |
| Details |
1) Those patients who required immediate intubation (<1hour),
2) low level of consciousness (GCS<10)
3) less than 24 hours of stay in PICU,
4) absent cough/ gag reflex,
5) hemodynamic instability
6)recent facial, upper airway or upper gastrointestinal tract surgery,
7)undrained pneumothorax
8)Hypercapnia (PCO2 > 60 mm of Hg),
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The need for invasive ventilation (primary outcomes) 

2. Complications during use and perception of ‘ease of use’ by nursing staff (secondary outcomes)
|
1st time point:6 hours
2nd time point:24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay ,duration of respiratory support |
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| Date of Study Completion (India) |
08/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Prospective Observational Study study will be performed at St John’s medical college hospital, an urban tertiary referral hospital with 12-bedded PICU. The children from 5 months of age to 58 months of age meeting the inclusion criteria will be enrolled in the PICU. Children with mild to moderate respiratory distress score will be started on B-CPAP. The severity of respiratory distress will be determined using following variables, (respiratory rate, air entry, retractions, grunt, saturation in room air and level of consciousness). These variables will be recorded and graded according to modified Wood-Downes score. The highest scores from each variable were summed to attain the total severity score and graded as :1- 3, mild; 4-7, moderate; 8-12, severe. (19)
Aims and Objective(s) of the Study This study is planned to look at its effectiveness of B-CPAP in reducing the need for invasive ventilation and its safety as a form of respiratory support in children with pneumonia. Primary objective: 1)To determine the efficacy and safety of Biodesign Innovation Labs’ Respap kit , a B-CPAP based oxygen therapy for children under 5 years with mild to moderate respiratory distress due to Pneumonia Secondary Objective: 2) To assess the complications during use of B-CPAP and perception of ‘ease of use’ by nursing staff 
 |