| CTRI Number |
CTRI/2025/07/089978 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ventilator settings] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of lung protective ventilation versus conventional ventilation on lung function in patients undergoing laparoscopic abdominal surgery under general anaesthesia |
|
Scientific Title of Study
|
A randomized controlled study of lung protective ventilation and conventional ventilation in patients undergoing abdominal laparoscopic surgeries under general anesthesia at SMS Medical College, Jaipur |
| 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 Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Verma |
| Designation |
PG Resident |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9098851662 |
| Fax |
|
| Email |
drprachi150281@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, 2nd floor, Dhanvantri complex SMS Medical College and Hospitals, Jaipur 302002, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospitals |
| Address |
Department of Anaesthesia, 2nd floor, Dhanvantri complex SMS Medical College and Hospitals, Jaipur 302002, Rajasthan , India |
| Type of Sponsor |
Government medical college |
|
|
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 Indu Verma |
General Surgery Laparoscopic OT II complex, SMS Medical College, Jaipur |
Department of Anaesthesia, 2nd floor, Dhanvantari complex, SMS Medical College, Jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K80||Cholelithiasis, (3) ICD-10 Condition: K55-K64||Other diseases of intestines, (4) ICD-10 Condition: K40-K46||Hernia, (5) ICD-10 Condition: N832||Other and unspecified ovarian cysts, (6) ICD-10 Condition: K81||Cholecystitis, (7) ICD-10 Condition: K82||Other diseases of gallbladder, (8) ICD-10 Condition: C20||Malignant neoplasm of rectum, (9) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional ventilation |
Received tidal volume 10 ml per kg, 0 cm of PEEP, no recruitment maneuvers. |
| Intervention |
Lung protective ventilation |
Received tidal volume 7 ml per kg, PEEP 10 cm of H2O, regular recruitment maneuvers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent.
2.Patients 18-60 years planned for laparoscopic surgeries.
3.American Society of Anaesthesiologists (ASA) grade I and II |
|
| ExclusionCriteria |
| Details |
1. Patient should not be part of any other study.
2. Pateints with the need to continue prolonged mechanical ventilation after surgery.
3. Patients with abnormal spirometry. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare intraoperative Pulmonary Oxygenation in both groups by calculating ratio of Partial pressure of oxygenation in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2), PaO2 (mmHg), PaCO2 (mmHg), PH values intraoperatively by Arteiral Blood Gas analysis |
After induction , 30 min after pneumoperitoneum and then at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare change in Hemodynamics parameters in both groups. |
After induction, 15min,
30 min , then hourly, 10 min before pneumoperitoneum gets closed and then at the end of surgery. |
| To assess and compare lung mechanics in both groups |
After induction, 15min,
30 min , then hourly, 10 min before pneumoperitoneum gets closed and then at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
12/07/2025 |
| 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="5"
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
|
This prospective, randomized comparative study is being conducted at SMS Medical College and Hospital, Jaipur, to evaluate the effects of lung protective ventilation (LPV) versus conventional ventilation (CV) strategies on pulmonary function in patients undergoing elective abdominal laparoscopic surgery under general anesthesia. A total of 188 patients will be enrolled and randomized into two equal groups (LPV and CV). Parameters such as arterial blood gas values, ventilatory mechanics, and intraoperative hemodynamic changes will be recorded at predefined time intervals. The aim is to assess whether LPV improves intraoperative pulmonary outcomes without adverse hemodynamic effects, thereby supporting safer anesthetic practices in laparoscopic procedures. |