| CTRI Number |
CTRI/2026/02/102905 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Finding the best breathing support to keep oxygen levels safe during laparoscopic surgery” |
|
Scientific Title of Study
|
Effect of two different levels of positive end expiratory pressure PEEP on oxygenation and ventilation during pneumoperitoneum for laparoscopic surgery in adults A randomized controlled 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 NIKHIL MARTUR |
| Designation |
JUNIOR RESIDENT ANAESTHESIA |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology
BLDE(Deemed to be University) Shri B.M Patil Medical College Hospital and
Research Centre, Vijayapura – 586103,
Karnataka.
Bijapur
KARNATAKA
586103
India |
| Phone |
8296398769 |
| Fax |
|
| Email |
nikhilmartur97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAYKUMAR T K |
| Designation |
MD Anaesthesiology Professor |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology
BLDE(Deemed to be University) Shri B.M Patil Medical College Hospital and
Research Centre, Vijayapura – 586103,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
Vijaykumar.tk@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIJAYKUMAR T K |
| Designation |
MD Anaesthesiology Professor |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology
BLDE(Deemed to be University) Shri B.M Patil Medical College Hospital and
Research Centre, Vijayapura – 586103,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
Vijaykumar.tk@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
BLDE(Deemed to be University) Shri B.M Patil Medical College Hospital and
Research Centre, Vijayapura – 586103,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
BLDE(Deemed to be University) Shri B.M Patil Medical College Hospital and
Research Centre, Vijayapura – 586103,
Karnataka |
| 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 NIKHIL MARTUR |
Shri B.M Patil Medical College Hospital and Research Centre |
3rd floor ot complex,Department of Anaesthesiology,Vijayapura – 586103,
Karnataka
Bijapur
KARNATAKA |
8296398769
nikhilmartur97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARENCE CERTIFICATE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arterial Blood Gas (ABG) Analysis at different time points |
Arterial Blood Gas (ABG) Analysis:
T1- Baseline (post-induction).
T2- Five minutes after pneumoperitoneum.
T3-One hour after application of PEEP during pneumoperitoneum.
T4-After desufflation
|
| Comparator Agent |
the effect of positive end-expiratory pressure levels (PEEP-5/10)on oxygenation during pneumoperitoneum for laparoscopic surgery in adults |
To assess ventilation and hemodynamic changes associated with different levels of PEEP during laparoscopic surgery and to evaluate the effect of PEEP (5/10) on arterial carbon dioxide (PaCO2) during pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II.
Duration of surgery expected to exceed 60 minutes.
BMI between 18.5 and 30 kg/m2
|
|
| ExclusionCriteria |
| Details |
Patients with history of significant pulmonary diseases
(Eg:COPD, ASTHMA, RESTRICTIVE LUNG DISEASES).
Patients with neuromuscular disorders or chest wall deformities.
Pregnant women and lactating mothers.
Known or suspected cardiovascular instability or heart failure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effect of two different levels of positive end-expiratory pressure levels (PEEP) on oxygenation during pneumoperitoneum for laparoscopic surgery in adults by doing arterial blood gas analysis |
T1- Baseline (post-induction).
T2- Five minutes after pneumoperitoneum. T3-One hour after application of PEEP during pneumoperitoneum.
T4-After desufflation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1- To assess ventilation & hemodynamic changes associated with different levels of PEEP during laparoscopic surgery |
Arterial Blood Gas (ABG) Analysis:
T1- Baseline (post-induction).
T2- Five minutes after pneumoperitoneum.
T3-One hour after application of PEEP during pneumoperitoneum.
T4-After desufflation
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
13/02/2026 |
| 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 Yet Recruiting |
| 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
|
patients are randomly allocated into 2 groups based on peep levels.group A receives low peep 5 and group B receives high peep 10.all patients undergo volume controlled ventilation with low tidal volume,standardised fio2 and fixed peep during pneumoperitoneum.ventilation settings incude I E ratio 1:1,peak pressure less than 16 cm h2o,RR adjusted for normocapnia.anaesthesia induction maintenance ,muscle relaxation and analgesia follow normal institutional protocol.haemodynamic,respiratory parameters and ABG value are recorded at base;line,during pneumoperitoneum and postoperatively. |