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CTRI Number  CTRI/2025/09/095058 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Driving pressure guided positive end expiratory pressure (PEEP) vs fixed PEEP in preventing lung collapse. 
Scientific Title of Study   Comparison of driving pressure guided optimum versus fixed positive end expiratory pressure to prevent atelectasis of lungs in paediatric laparoscopic abdominal surgery cases a prospective randomised double blind study 
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 Tripti Gautam 
Designation  PG JR 
Affiliation  AIIMS Raipur 
Address  Seminar room, Paediatric surgery OT, OT Complex, Super-speciality complex, Department of Anaesthesiology, 4th floor, B Block, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8941012466  
Fax    
Email  triptigautam016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Kumar 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Faculty room no. 3, A block, Department of Anaesthesiology, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayank Kumar 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Faculty room no. 3, A block, Department of Anaesthesiology, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, TATIBANDH, GE ROAD, RAIPUR, CHHATTISGARH, INDIA, 492099 
 
Primary Sponsor  
Name  AIIMS, RAIPUR 
Address  AIIMS, G.E. Road, Tatibandh, Raipur, Chhattisgarh, 492099 
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 Tripti Gautam   AIIMS RAIPUR  Office Room Anesthesia, Department of Anesthesiology, B block OT complex, 4th floor, AIIMS Raipur, G.E Road, Tatibandh
Raipur
CHHATTISGARH 
8941012466

triptigautam016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE AIIMS RAIPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K40-K46||Hernia, (2) ICD-10 Condition: K35-K38||Diseases of appendix, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: N40-N53||Diseases of male genital organs, (5) ICD-10 Condition: K55-K64||Other diseases of intestines,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Driving pressure guided Optimum PEEP  In volume controlled mode, tidal volume of 6-7ml/kg, and PEEP of 4cmH2O will be set after intubation. Incremental PEEP protocol will be used starting from 2cmH2O, with increments of 1cmH2O ,done till 12cmH2O. Each PEEP will be maintained for 10 respiratory cycles, and the PEEP with lowest driving pressure will be fixed throughout the surgery. 
Comparator Agent  Fixed PEEP  A fixed PEEP of 4cmH20 will be set in volume controlled mode with tidal volume of 6-7 ml/kg and respiratory rate as per ge 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Patients of ASA GRADE 1 and 2 undergoing elective laparoscopic abdominal surgeries with informed consent 
 
ExclusionCriteria 
Details  Patient parents refusal
Pre-existing lung disease
Chest wall or thoracic spine deformity
Pre-existing significant cardiac, renal and hepatic diseases
Previous history of thoracic surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To identify whether driving pressure guided optimum PEEP can reduce the magnitude of post-operative (30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung score.  Lung ultrasound at baseline, before pneumoperitoneum, after deflation of pneumoperitoneum and before extubation, 30 minutes after shifting to PACU 
 
Secondary Outcome  
Outcome  TimePoints 
To compare post-operative pulmonary complication within three days of surgery  Post-operative 
To compare requirement of supplemental oxygen to maintain oxygen saturation more than 94% in postoperative period and on first postoperative day  Post-operative  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   28/09/2025 
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="0"
Months="10"
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 - NO
Brief Summary  
Atelectasis, defined as the incomplete expansion of the lungs, is a significant concern during anesthesia and surgery, particularly in pediatric laparoscopic procedures. It results from the collapse of small airways, leading to impaired gas exchange and increased postoperative complications. Factors contributing to atelectasis include positive pressure ventilation, which can exacerbate lung collapse, and mechanical challenges posed by pneumoperitoneum and patient positioning.
This research aims to evaluate the effectiveness of two ventilation strategies—driving pressure-guided optimum PEEP versus fixed PEEP—in preventing atelectasis in pediatric laparoscopic surgeries. Driving pressure-guided ventilation optimizes lung recruitment and minimizes overdistention by adjusting ventilator settings based on driving pressure, which has been linked to improved lung compliance and reduced risk of atelectasis.
The study acknowledges existing literature indicating that lung-protective ventilation strategies, such as low tidal volume and PEEP application, are crucial in mitigating ventilator-induced lung injury (VILI). However, driving pressure has emerged as a critical factor in patient outcomes, with high driving pressures correlating with increased mortality.

A review of literature highlights the physiological challenges in pediatric patients, including higher oxygen consumption and lower functional residual capacity, which increase the risk of hypoxemia. Several studies have shown that appropriate PEEP levels improve oxygenation and reduce atelectasis during laparoscopic surgery.
This prospective randomized double-blind study seeks to provide insights into the optimal ventilation strategy for minimizing atelectasis and improving respiratory outcomes in pediatric patients. By comparing driving pressure-guided PEEP and fixed PEEP, the research aims to enhance clinical practices in pediatric anesthesia and surgery, ultimately improving patient outcomes and reducing hospital stays.
 
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