| CTRI Number |
CTRI/2021/07/035055 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
16/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing methods of non invasive ventilation after pediatric cardiac surgery |
|
Scientific Title of Study
|
Comparative effect of High Frequency Nasal Cannula and Non Invasive Ventilation on the work of breathing and postoperative pulmonary complication after pediatric congenital cardiac surgery : A prospective randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alisha Goel |
| Designation |
Senior resident, DM Cardiac Anaesthesia |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09467076320 |
| Fax |
|
| Email |
alishag93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Kumar |
| Designation |
Proffesor, DM Cardiac Anaesthesia |
| Affiliation |
Proffesor, Department of Anesthesia, PGIMER CHANDIGARH |
| Address |
Advanced Cardiac Centre
PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
07087009511 |
| Fax |
|
| Email |
bhupeshkr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ALISHA GOEL |
| Designation |
Senior resident, DM Cardiac Anaesthesia |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
PGIMER CHANDIGARH
opp APC
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09467076320 |
| Fax |
|
| Email |
alishag93@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER Research Grant Fund |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Alisha Goel |
CTVS ICU |
4th floor
ADVANCED CARDIAC CENTRE, PGIMER
CHANDIGARH
160012
Chandigarh
CHANDIGARH |
09467076320
alishag93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HFNC; SIPAP |
high frequency nasal cannula to deliver high humidified oxygen at high oxygen concentration; or Sigh PAP device is a form of bilevel PAP to deliver two levels of positive airway pressure for better lung recruitment
post extubation till p/f ratio 300 |
| Intervention |
RAMS CANNULA NIV |
non invasive ventilation delivered by ventilator through the RAMS CANNULA as the interface
post extubation till p/f ratio 300 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
post cardiac surgery belonging to RACHS GROUP 1,2 |
|
| ExclusionCriteria |
| Details |
Neonates
Preoperative respiratory compromise
Preoperative requirement of mechanical ventilation
Emergency surgery
Residual anatomical defects etc.
Diaphragmatic palsy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the magnitude of decrease in respiratory workload by HFNC, NIPPV and SIPAP as assessed using diaphragmatic thickening fraction and 2D longitudinal strain. |
at extubation, D1, D2, D3,D4,D5,D6,D7,D8,D9,D10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in oxygenation (P/F ratio; ROX index)
Proportion of patients that require reintubation till 48 hours post extubation and until discharge from ICU.
Switching to other treatment options or premature treatment discontinuation(NIV/HFNC failure)
Incidence of complications like atelectasis, collapse, pneumothorax, abdominal distension, feed intolerance,etc.
Correlation between Strain and DTF as a measure of diaphragmatic function
Compliance for the device
|
at extubation, D1, D2, D3,D4,D5,D6,D7,D8,D9,D10 |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
compares different methods of non invasive ventilation- HFNC, NIV, SIPAP for pediatric cardiac surgery patients post extubation to prevent pulmonary complications. It will also compare their efficacy in terms of work of breathing using ultrasound and also study any side effects. |