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CTRI Number  CTRI/2024/03/064676 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Incremental ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the difference between fixed and increased positive end expiratory pressure on lung compliance in adults patients undergoing surgery under general anaesthesia. 
Scientific Title of Study   Effect of fixed versus incremental positive end expiratory pressure on intraoperative lung compliance in adult patients undergoing surgery under general anaesthesia : A randomized controlled 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  Ankita Dey 
Designation  Post graduate resident 
Affiliation  AIIMS Bathinda 
Address  Department of Anaesthesiology and critical care,AIIMS Bathinda,Mandi Dabwali Road,Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9101797504  
Fax    
Email  ankitadey490@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences ,Bathinda 
Address  Department of Anaesthesiology and Critical Care,room no.140, AIIMS Bathinda, Mandi Dabwali Road,Bathinda,Punjab

Bathinda
PUNJAB
151001
India 
Phone  9968583915  
Fax    
Email  doctorjyotisharma@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gopal Krishan Jalwal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences ,Bathinda 
Address  Department of Anaesthesiology and Critical Care,room no.143,AIIMS Bathinda,Mandi Dabwali Road,Bathinda,Punjab

Bathinda
PUNJAB
151001
India 
Phone  7838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology and Critical Care,All India Institute of Medical sciences, Bathinda,Mandi Dabwali road,PIN-151001,Punjab  
 
Primary Sponsor  
Name  All India Institute of Medical sciences, AIIMS Bathinda  
Address  All India Institute of Medical sciences, AIIMS Bathinda  
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 Ankita Dey  All India Institute of Medical sciences Bathinda   Department of Anesthesiology and Critical Care, All India Institute of Medical sciences Bathinda,Mandi-Dabwali Road, PIN-151001,Punjab
Bathinda
PUNJAB 
9101797504

ankitadey490@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A-Fixed PEEP  Fixed PEEP of 5cm H2O will be kept throughout the surgery.Static lung compliance will be calculated at every 15min interval starting from induction till 45min. 
Intervention  Group B-Incremental PEEP  Incremental PEEP of 5,7,9cm H2O will be applied at every 15min interval and static lung compliance will be calculated at each step. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients undergoing surgery under general anaesthesia with an anticipated surgical duration
≥120minutes.
2. Adult patients aged between 18-65years.
3. ASA physical status I to III patients.
 
 
ExclusionCriteria 
Details  1. Patient refusal of consent.
2. Patients with history of any lung pathology.
3. Patients undergoing neurosurgeries
4. Pregnant patients.
5. Patients already on mechanical ventilation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the difference between fixed and incremental PEEP on intraoperative static lung compliance in adult patients undergoing surgery under general anaesthesia  Static lung compliance will be calculated at 3 time points at every 15minutes starting from induction. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate immediate post operative pulmonary complications assessed by ultrasonography in adult patients undergoing surgery under general anaesthesia with fixed or incremental PEEP.  At two time points:1 hour after extubation and 24 hours after extubation. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 15/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/08/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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   After enrollment, the patients will be shifted to operation theatre and placed in supine position. Standard ASA monitors will be attached. Baseline parameters such as heart rate(HR),systolic blood pressure(SBP), and diastolic blood pressure(DBP), mean arterial pressure (MAP),oxygen saturation (SpO2)will be noted. A wide bore intravenous (IV) cannula will be inserted. 
Following preoxygenation for 3minutes, induction of anaesthesia will be done with injection midazolam (0.02mg/kg), Propofol(2-2.5mg/kg) and Fentanyl(2mcg/kg). After checking the ability to ventilate, Vecuronium (0.1mg/kg) will be administered as a muscle relaxant following which patients will be manually ventilated for 3 minutes. Laryngoscopy will be performed using appropriate size laryngoscopy blade. Endotracheal intubation will be done using appropriate size tube and the airway will be secured. After intubation, general anaesthesia will be maintained with oxygen & air (50:50), isoflurane (Minimum alveolar concentration 
1.0). 
All patients will be ventilated using a closed circuit with the ventilator setting being volumecontrolled mechanical ventilation, with 6-8ml/kg tidal volume, fraction of inspired oxygen 50%, inspiratory: expiratory ratio will be 1:2, and respiratory rate will be adjusted to maintain an end-tidal carbon dioxide of 30-35 mmHg. Normothermia will be maintained throughout the surgery. 
In Group A, a fixed PEEP of 5cm H2O will be delivered throughout the procedure. Static lung compliance will be calculated at three points with 15 minutes interval starting from induction. 
In Group B, incremental PEEP of 5,7 and 9 cm H2O will be delivered at every 15 minutes interval and static lung compliance will be measured at each step keeping Pplat<30 .(16) Static lung compliance (Cs) can be calculated as follows(15): 
Cs=Vt/(Pplat-PEEP)
 Where 
Vt is the Tidal volume. 
Pplat is the plateau pressure. 
Pplat is measured at the end of inspiration by holding the inspiration for few seconds. 
PEEP will be decreased gradually from 9 cm H2O over the next 15 minutes and a PEEP of 5 cm H2O will be maintained throughout the procedure after that. 
Fluids will be given as required and amount and type of fluid will be noted. Any episode of acute hypotension during the study will be treated with Inj. Mephentermine 6mg I/V.  
At the end of the procedure, reversal of neuromuscular blockade will be done using Inj. Neostigmine 0.03-0.07mg/kg with Inj.Glycopyrrolate 0.01mcg/kg. Extubation will be done only after full reversal of neuromuscular blockade with a TOF ratio of more than 0.9 and the patient following verbal commands and ventilating spontaneously. After extubation, the patient will be shifted to postoperative area. Any episode of desaturation (SpO2<92%) will be treated with oxygen supplementation. The patients will be observed for immediate postoperative pulmonary complications using lung ultrasound at two time points:1 hour after extubation(T1) and 24 hours after extubation(T2). 
Low frequency curvilinear (2-5 MHz) probe of the SonoSite Fujifilm Edge II inc.USA 
Ultrasound System will be used for lung ultrasound scanning. Each side of the thorax will be divided into six zones by two vertical (anterior and posterior axillary lines) and one imaginary horizontal line (passing above the nipple), so a total of 12 lung areas will be scanned. Intercostal spaces of each of these areas will be scanned, and an image of the most pathologic area of each quadrant will be saved to digital format for offline analysis and scoring. 
The scoring of lung ultrasound will be done according to a modified lung ultrasound scoring 
(mLUS) system.(9) 
According to the mLUS system, 
Score 0: A-line profile or up to two B-line separated by regular pleural lines. 
Score 1: if there are three or more B-lines with or without small subpleural consolidation and a regular pleural line.  
Score 2: if there are coalescent B-lines and or small subpleural consolidation with an irregular pleural line in between. 
Score 3: if extensive subpleural consolidation is more than 1x2 cm. 
Detailed ultrasound Based upon the mLUS scoring system, each area was scored from 0-3, so a minimum zero or maximum 36 score is possible. Lung ultrasound will be performed at two predefined time points, 1hour after extubation and 24hours after extubation of the trachea.
 
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