| CTRI Number |
CTRI/2024/04/065634 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of postive pressure inside lung during no ventilation during heart surgery in children |
|
Scientific Title of Study
|
Continuous positive airway pressure during cardio pulmonary bypass and postoperative pulmonary complications among children undergoing congenital heart surgery:A randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Jemima Tamilmalar.S |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical education and Research |
| Address |
Department of Anesthesiology and Critical Care, 2nd Floor, Main Hospital Block, Jawaharlal Institute of Postgraduate Medical Education and Research, puducherry, INDIA, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09868477642 |
| Fax |
|
| Email |
jemiponraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSandeep Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,Jawaharlal Institute of Postgraduate Medical education and Research,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344668104 |
| Fax |
|
| Email |
jipmermishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSandeep Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,Jawaharlal Institute of Postgraduate Medical education and Research,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344668104 |
| Fax |
|
| Email |
jipmermishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| DrJemima TamilmalarS |
Jawaharlal Institute of Medical Education and Research |
Department of Anesthesiology and Critical Care, 2nd Floor, Main Hospital Block, Jawaharlal Institute of Postgraduate Medical Education and Research, puducherry, INDIA, 605006
Pondicherry
PONDICHERRY |
9486548131
jemiponraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research ethics committee |
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 |
| Intervention |
Giving continuous positive airway pressure during cardiopulmonary bypass in children undergoing Congenital heart surgery |
Children less than one year will receive continuous positive airway pressure of 2 cm H2o,children between one to two years will receive 3 cmH2o continuous airway pressure , children between two to four years will receive continously positive airway pressure of 4 cm H2O, children more than five years will receive continuous positive airway pressure of five cmH2o throughout the period of cardiopulmonary bypass which is usually one to three hours |
| Comparator Agent |
Proceeding with cardiopulmonary bypass during heart surgery in children without age specific continuous positive airway pressure |
Lung will remain deflated throughout the period of cardiopulmonary bypass which usually lasts for one to three hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children till 12 years of age undergoing congenital heart surgery under cardiopulmonary bypass |
|
| ExclusionCriteria |
| Details |
1.Known respiratory disease
2.Already receiving invasive or noninvasive mechanical ventil
3.Chestwall deformity |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of continuous positive airway pressure on postoperative pulmonary complications in children undergoing congenital heart surgery |
Everyday starting from postoperative day one till the day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effect of continuous positive airway pressure during cardiopulmonary bypass on duration of mechanical ventilation
2. To evaluate the effect of continuous positive airway pressure during cardiopulmonary bypass on extubation time
3. To evaluate the effect of continuous positive airway pressure during cardiopulmonary bypass on percent of patient not requiring oxygen support on seventh postoperative day
4. To evaluate the effect of continuous positive airway pressure during cardiopulmonary bypass on duration of intensive care unit and hospital stay
5. To evaluate the effect of continuous positive airway pressure during cardiopulmonary bypass on mortality rate |
Every day starting from postoperative day one till the day of discharge |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is conducted in children born with heart diseases undergoing heart surgery. We are providing continuous positive airway pressure to these patients at the time cardiopulmonary bypass during surgery and we will be analysing its effects on postoperative pulmonary problems. |