| CTRI Number |
CTRI/2022/01/039351 [Registered on: 12/01/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ventilator PEEP ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intraoperative use of PEEP in post covid patients and improvement in oxygenation. |
|
Scientific Title of Study
|
Intraoperative adherence of lung protective ventilation in improvement of oxygenation with fixed PEEP and individualised PEEP in post covid patients under general anaesthesia -A randomised 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 |
Mutharasan S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
A BLOCK OT 4 th floor Department of anaesthesia AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8248946847 |
| Fax |
|
| Email |
muthuarasan999999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chinmaya Kumar Panda |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Raipur |
| Address |
A BLOCK OT 4 th floor Department of anaesthesia AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8098007711 |
| Fax |
|
| Email |
chinmaya.panda06@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSMutharasan |
| Designation |
PG JR |
| Affiliation |
AIIMS Raipur |
| Address |
A BLOCK OT 4 th floor Department of anaesthesia AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8248946847 |
| Fax |
|
| Email |
muthuarasan999999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
AIIMS Raipur Tatibandh Raipur Chhattisgarh |
| 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 Mutharasan |
AIIMS Raipur |
A block OT 4th floor Department of anaesthesia AIIMS Raipur Raipur CHHATTISGARH |
8248946847
muthuarasan999999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed PEEP and individualised PEEP |
Pa02 /Fi02 ratio |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age > 18 years.
2. Post COVID-19 infection posted for surgery under general anaesthesia.
3. Elective and emergency surgeries.
4. ASA PS- I-III
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) Alveolar-arterial oxygen gradient (A-a O2) |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dynamic compliance (Cdyn) during intraoperative period,
2. Incidence of postoperative pulmonary complications (PPC),
3. Length of ICU stays,
4. Length of hospital stays,
5. In-hospital mortality
|
patient will be followed throughout the length of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
21/01/2022 |
| 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="6" Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be decided after the study got over. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As evidence-based practice has evolved, potential harmful effects of traditional non physiological mechanical ventilation even for a short term have been shown to correlate with increased incidence of ventilator associated lung injury (VILI). On the other hand, intraoperative lung protective ventilation has been shown to decrease pulmonary complication. The goal of this intervention is to minimize alveolar overdistention, to prevent repeated collapse and reopening of alveoli and to reduce atelectasis which is expected in a traditional ventilation. There have been several trials comparing lung protective strategies with different level of positive end expiratory pressure in various surgeries. This study focuses on comparing individualised PEEP with a fixed PEEP in post COVID patients with an intention to improve intraoperative oxygenation, pulmonary mechanics and early post-operative complication. This study has not been done so far to the best our knowledge. |