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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  
AIIMS Raipur  
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  AIIMS Raipur Tatibandh Raipur Chhattisgarh  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
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