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CTRI Number  CTRI/2025/08/093215 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 17/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing low vs high breathing support settings on lung stress and breathing function in patients with chest injuries during surgery. 
Scientific Title of Study   Effect of low positive end expiratory pressure (PEEP) vs recruitment followed high PEEP on mechanical power and respiratory mechanics in patients with blunt thoracic trauma undergoing non thoracic surgery: A randomised control 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. Rushika Kowdipally  
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care Room 5011, 5th floor, Academic Block

South
DELHI
110029
India 
Phone  7997031914  
Fax    
Email  rushikakowdipally@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Abhishek Singh  
Designation  Assistant professor  
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care Room 5011, 5th floor, Academic Block

South
DELHI
110029
India 
Phone  8287652624  
Fax    
Email  bikunrs77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Abhishek Singh  
Designation  Assistant professor  
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care Room 5011, 5th floor, Academic Block

South
DELHI
110029
India 
Phone  8287652624  
Fax    
Email  bikunrs77@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  Ansari Nagar east , New Delhi,110029 
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 Rushika Kowdipally   AIIMS Hospital   Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, Ansari Nagar -110029
South
DELHI 		 7997031914

rushikakowdipally@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS,NEW DELHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low PEEP group Duration: Throughout the surgery.  PEEP will be set at 5cm H2O throughout the surgery.Patients will undergo volume controlled mechanical ventilation with FiO2 of more than 0.4 to maintain a peripheral oxyhemoglobin saturation of more than 94%, an inspiratory-to-expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (35 and 45 mmHg).  
Intervention  Recruitment followed High PEEP. Duration: Recruitment for 30 seconds, High PEEP throughout the surgery   Recruitment will be done by sustained inflation technique, in which a continuous pressure of 30cm H2O will be applied to the airways for 30 seconds followed by application of High PEEP at 10cm H2O throughout the surgery. Patients will undergo volume controlled mechanical ventilation with FiO2 of more than 0.4 to maintain a peripheral oxyhemoglobin saturation of more than 94%, an inspiratory-to-expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (35 and 45 mmHg).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults with blunt thoracic trauma undergoing non thoracic surgery under general anaesthesia with mechanical ventilation. 
 
ExclusionCriteria 
Details  a) Patient refusal to participate in the study
b) Known COPD or other chronic lung diseases.
c) Patients with penetrating thoracic trauma.
d) Pre existing cardiac dysfunction.
e) Patients undergoing thoracic or cardiac surgery.
f) Presence of uncontrolled arrhythmias or significant hemodynamic instability.
g) Moderate to severe traumatic brain injury.
h) Pregnancy
I) Patients already intubated and ventilated for more than 24 hours prior to surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mechanical power differences between low PEEP and recruitment followed high PEEP groups during intra operative ventilation   After Induction, every 30 minutes and at the end of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess differences in respiratory mechanics  After induction, every 30 minutes and at the end of surgery. 
To evaluate oxygenation   After induction, every 30 minutes and at the end of surgery. 
To compare hemodynamic effects  After induction, every 30 minutes and at the end of surgery. 
To assess post operative pulmonary complications  Upto 48 hours after surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   01/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhishek.aiims14@gmail.com].

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 30-06-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Patients with blunt thoracic trauma undergoing non thoracic surgery will be screened for inclusion criteria during preoperative anesthesia check up.  Once a patient fulfills the inclusion criteria, they will be informed about the aim and methodology of the study and informed consent will be obtained
      Demographic, clinical, radiological and laboratory data will be collected from each participant (as available):
Age, sex, BMI, mechanism of injury, type of injury, time since injury, type of surgery, co morbidities, addiction habits, chest X-ray, hemogram, renal function tests, liver function tests, serum electrolytes, echo, ECG.
      In the operating room, standard monitoring as per American Society of Anesthesiologists’ recommendation (3- lead ECG or 5 lead ECG as per requirement of the patient, pulse oximetry, NIBP) will be initiated, intravenous cannulation will be secured, Baseline vitals- Heart rate (HR), Systolic BP (SBP), Diastolic BP(DBP), Mean BP(MAP), SpO2 will be recorded. Baseline ABG will be taken and PaO2, PaCO2, FiO2 will be recorded. 
Induction: Anesthesia will be induced with IV Fentanyl 2 microgram per kg, Propofol 2mg per kg and Atracurium 0.5mg per kg. Following which endotracheal intubation will be done. 
Patients will undergo volume controlled mechanical ventilation, with an inspiratory to expiratory ratio (I:E) of 1:2, and a respiratory rate adjusted to normocapnia (35 to 45 mmHg). Tidal volume is set to 7ml per kg (PBW). 
Maintenance: Anesthesia will be maintained with oxygen, air and isoflurane. Thereafter the patient will be randomized into the following 2 groups using computer generated table of random number. 
1. RM+ High PEEP Group: Recruitment will be done by sustained inflation technique, in which a continuous pressure of 30cm H2O will be applied to the airways for 30sec followed by application of high PEEP at 10cm H2O.
2. Low PEEP Group: PEEP set at 5cm H2O.
   Intra operative lung mechanics i.e peak inspiratory pressure, mean airway pressure, plateau pressure, driving pressure and mechanical power will be calculated post induction, every 30minutes thereafter, and till the end of surgery before extubation in both the group.
Mechanical power of ventilator in Joules per min will be calculated.
ABG will be done post induction, every 30 minutes and at the end of surgery to assess PaO2, Alveolar arterial gradient, Respiratory index. Alveolar arterial gradient and Respiratory index will be calculated.
HR, SBP, DBP, MAP are recorded post induction, every 30 minutes, and at the end of surgery. Incidence of hypotension, need for vasopressor will be recorded.  The MAP in both the groups will be targeted to more than 70mmHg. Intravenous ephedrine or norepinephrine will be used if required.
In both the groups, allowable blood loss (ABL) will be calculated.
Any volume of blood lost during the surgery below the calculated ABL will be replaced with crystalloids. The volume of blood lost more than the calculated ABL will be replaced with cross matched blood.
In both the groups, the patient will be sub-divided on the basis of chest trauma score for studying the impact of PEEP in BTT patients with varying degree of chest trauma.
 
Participants will be followed up to look for the development of Post operative pulmonary complications ( Barotrauma, Pulmonary edema, Pleural effusion, Bronchospasm, acute respiratory distress syndrome, Respiratory failure, new pulmonary infiltrates) for upto 48 hours post-surgery.
Protocol deviation: Anesthesiologists may deviate from the ventilation protocol at any time if concerns about patient safety arises. PEEP may be modified according to the anesthesiologist’s judgment in the presence of any of the following clinical situations: 1.Decrease in systolic arterial pressure less than 90mmHg and unresponsive to fluids and/or vasoactive drugs. 2. Need for a dosage of vasoactive drugs at the tolerance limit. 3. New arrhythmias unresponsive to the treatment suggested by the Advanced Cardiac Life Support Guidelines. 4. Blood loss requiring massive transfusion. 
 
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