| 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
|
|
|
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
|
|
|
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. |