| CTRI Number |
CTRI/2025/09/094483 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Inspiratory-to-Expiratory Ratios in Patients on Ventilators During Laparoscopic Surgery |
|
Scientific Title of Study
|
Comparison of Three Inspiratory-to-Expiratory Ratio During Mechanical Ventilation in Patients Undergoing Laparoscopic Surgeries: A Randomized Clinical 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 |
Dr Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 1, Department of Anaesthesia, Vinayaka Missiosn Medical College And Hospital, Keezhakasakudy, Kottucherry Post, Karaikal, Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramya Ramesh |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 2, Department of Anaesthesia, Vinayaka Missiosn Medical College And Hospital, Keezhakasakudy, Kottucherry Post, Karaikal, Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9526395712 |
| Fax |
|
| Email |
ramyaramesh9831@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya Ramesh |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 2, Department of Anaesthesia, Vinayaka Missiosn Medical College And Hospital, Keezhakasakudy, Kottucherry Post, Karaikal, Puducherry
PONDICHERRY
609609
India |
| Phone |
9526395712 |
| Fax |
|
| Email |
ramyaramesh9831@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College and Hospital,
Keezhakasakudimedu, Kottuchery Post, Karaikal, Puducherry, India-609609 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College and Hospital |
| Address |
Vinayaka Missions Medical College and Hospital, Keezhakasakudy, Kottucherry Post, Karaikal, Puducherry 609609 |
| Type of Sponsor |
Private 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 Ramya Ramesh |
Vinayaka Missions Medical College and Hospital |
Department Of Anaesthesiology, Vinayaka Missions Medical College and Hospital,Keezhakasakudymedu, Kottuchery Post, Puducherry- 609609
Karaikal
PONDICHERRY
Karaikal
PONDICHERRY |
9526395712
ramyaramesh9831@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Patient to be ventilated with Inspiratory to Expiratory ratio of 1:1.5 |
| Intervention |
Group B |
Patient to be ventilated with Inspiratory to Expiratory ratio of 1:2 |
| Comparator Agent |
Group C |
Patient to be ventilated with Inspiratory to Expiratory ratio of 1:2.5 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status I and II
2) Patients scheduled for elective laparoscopic surgeries
3) BMI 18.5 to 30 kg per metre square
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal
2) History of COPD, asthma, or restrictive lung disease
3) History of significant cardiovascular disease
4) Severe hepatic or renal impairment
5) Pregnancy
6) Emergency surgeries
• BMI greater than 30 kg per metre square
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of volume-controlled ventilation with I:E ratios of 1:1.5, 1:2, and 1:2.5 on respiratory mechanics in patients undergoing laparoscopic surgeries. |
0 min, 15 mins, 30 mins, 60 mins, after desufflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of these three I:E ratios on gas exchange parameters and hemodynamic variables during pneumoperitoneum. |
0 min, 15 mins, 30 mins, 60 mins, after desufflation |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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="1"
Months="6"
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
|
Summary
This prospective, randomized clinical trial compares the effects of three different inspiratory-to-expiratory ratios , 1:1.5, 1:2, and 1:2.5 , during volume-controlled mechanical ventilation in adult patients undergoing laparoscopic surgeries.
A total of 75 patients , ASA I and II, aged 18 to 59 years, will be randomly assigned to one of the three groups. Standard anesthesia will be administered, and ventilation settings will be adjusted according to group allocation. Primary outcomes include respiratory mechanics such as peak airway pressure, plateau pressure, dynamic compliance, and airway resistance. Secondary outcomes include gas exchange parameters and hemodynamic stability during pneumoperitoneum.
The study aims to identify the optimal I:E ratio for improving lung mechanics and oxygenation while maintaining cardiovascular stability during laparoscopic upper abdominal surgeries. The findings are expected to guide anesthesiologists in selecting evidence-based ventilation strategies that may reduce postoperative pulmonary complications. |