| CTRI Number |
CTRI/2025/06/088917 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective study to compare the efficacy of Volume controlled ventilation and Pressure controlled ventilation in preventing post operative complications in patients undergoing off pump coronary artery bypass grafting. |
|
Scientific Title of Study
|
A Prospective Randomised study to compare the efficacy of volume controlled ventilation and pressure support ventilation in patients undergoing coronary artery bypass grafting off pump surgeries. |
| 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 Kiran Muthu Rajah |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
87, 5th street, Dr Kothari nagar, Ramapuram, Chennai
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research, no.1, Mount Poonamallee road, Porur
Chennai
TAMIL NADU
600089
India |
| Phone |
9600001484 |
| Fax |
|
| Email |
kiranmuthurajah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.Kiran Muthu Rajah
6th floor,Sri Ramachandra Institute of Higher Education and Research,
Sri Ramachandra nagar, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Kiranmuthrajah |
| Address |
C-6,Sri Ramachandra Institute of Higher Education and Research,
Sri Ramachandra nagar, Porur, Chennai-600116 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrKiran Muthu Rajah |
Sri Ramachandra Institute of Higher Education and Research |
6th floor, Udayar block, Sri Ramachandra Nagar, Mount Poonamallee road, Porur
Chennai
TAMIL NADU |
9600001484
kiranmuthurajah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the efficacy of volume control ventilation and pressure support ventilation by comparing the post operative pulmonary complications in patients undergoing coronary artery bypass grafting off pump. |
To compare the post operative pulmonary complications of both ventilatory modes and to assess the efficacy amongst them. |
| Comparator Agent |
To compare the post operative pulmonary complications during post operative day 0 / 1 / 2 in patients undergoing coronary artery bypass grafting off pump in both the modes of ventilation. (volume controlled ventilation and pressure controlled ventilation) |
To assess - Atelectasis, Pulmonary Edema ,PaO2/FiO2 Ratio, EtCO2 ,Pneumothorax, Pleural effusion, Dense consolidation, Pulmonary edema ,Inspiratory efforts during post operative day 0 / 1 / 2 in patients undergoing coronary artery bypass grafting off pump with both volume controlled ventilation and pressure controlled ventilation modes. To assess the efficacy amongst both the modes of ventilation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years of age or older
2. Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy |
|
| ExclusionCriteria |
| Details |
1. Patients were excluded in case of emergent or redo surgeries
2. Patients with history of COPD.
3. Patients with known pulmonary Hypertension
4. Patients with EF less than 40% in Echocardiography
5. Patients with significant history of smoking addiction
6. Body mass index more than 35 kg/ m2
7. Obstructive sleep apnea
8. Patient Refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of post-operative pulmonary complications:
(Post-extubation respiratory failure, Bronchospasm, Severe trachea–bronchial congestion,
Respiratory acidosis, Suspected or confirmed pneumonia, Pleural effusion, Radiological
atelectasis, acute respiratory distress syndrome, prolonged invasive ventilation associated
with hypoxemia) |
30minutes/60minutes/2hours/4hours/8hour/16hours/24hours/48hours/72hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of ICU stay |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/06/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 comparative study aimed to evaluate the efficacy of volume controlled ventilation versus pressure controlled ventilation modes during surgery in preventing postoperative pulmonary complications in patients undergoing coronary artery bypass grafting. patients scheduled for elective CABG were randomly assigned to receive either VCV or PVC intraoperatively. The objective of the study was to assess the incidence of post operative pulmonary complications such as atelectasis, pneumonia, hypoxaemia and prolonged ventilation in postoperative period. The study aimed to identify the ventilation strategy that offers superior pulmonary protection and better postoperative respiratory outcomes. in patients undergoing CABG. |