| CTRI Number |
CTRI/2025/10/096538 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
A Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing breathing and lung problems after heart bypass surgery done through the chest bone and through a small side opening in the chest |
|
Scientific Title of Study
|
A Prospective Observational Study to Comparing Postoperative Pulmonary Complications in Patients Undergoing Off-Pump CABG Vs Minimally Invasive Off-Pump CABG. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ST ARISH |
| Designation |
Junior technologist (Respiratory care) |
| Affiliation |
Department of Cardiac Anesthesiology,Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116. |
| Address |
Department of Cardiac Anaesthesiology,
Division of Cardiothoracic Anaesthesia,
F6icu,
Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116.
Chennai
TAMIL NADU
600116
India |
| Phone |
8778305120 |
| Fax |
|
| Email |
arishst2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ranjith Karthekeyan.B |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Cardiac Anesthesiology,Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116. |
| Address |
Department of Cardiac Anesthesiology, Division of cardiothoracic Anaesthesia, F6ICU,
Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116.
Chennai
TAMIL NADU
600116
India |
| Phone |
91 - 44 – 45928615(OFF) |
| Fax |
|
| Email |
ranjithb73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ST ARISH |
| Designation |
Junior technologist (Respiratory care) |
| Affiliation |
Department of Cardiac Anesthesiology,Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116. |
| Address |
Department of Cardiac Anaesthesiology,
Division of Cardiothoracic Anaesthesia,
F6icu,
Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116.
Chennai
TAMIL NADU
600116
India |
| Phone |
8778305120 |
| Fax |
|
| Email |
arishst2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116.
|
|
|
Primary Sponsor
|
| Name |
Dr Ranjith Karthekeyan B |
| Address |
Sri Ramachandra Institute of Higher Education and Research, No. 1, Ramachandra Nagar, Porur, Chennai – 600 116. |
| 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 |
| ST Arish |
Sri Ramachandra institute of higher education and research |
Department of Cardiac Anaesthesiology,
Division of Cardiothoracic Anaesthesia,
F6icu.
Chennai
TAMIL NADU |
8778305120
arishst2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for elective off-pump CABG with general anesthesia, invasive mechanical ventilation, conventional median sternotomy or minimally invasive thoracotomy. |
|
| 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 forty five percentage in Echocardiography
5.Patients with significant history of smoking addiction
6.Body mass index greater than thirty five kilograms per square meter
7.Patient Refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of postoperative pulmonary complications assessed using composite scoring, including Postoperative Atelectasis Severity Score, CURB-65 Severity Score, Ventilator Dependence Severity Score, Pleural Effusion Severity Score, and Asthma Severity Score (adapted for Bronchospasm), in patients undergoing Off-Pump CABG and Minimally Invasive Off-Pump CABG. |
Assessed at twenty four, forty eight and seventy two hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of extubation from completion of surgery,
Need for re-intubation,
Duration of ICU stay, Post extubation ABG(pao2/fio2 ratio,pH, PaCO2), number of grafts used. |
Assessed at twenty four, forty-eight, & seventy two hours. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
15/11/2025 |
| 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
|
Coronary artery bypass grafting is a standard surgical procedure for the management of coronary artery disease. Conventional off pump coronary artery bypass grafting performed through median sternotomy may be associated with postoperative pulmonary complications such as atelectasis, pneumonia, pleural effusion,. and respiratory failure. Minimally invasive off pump coronary artery bypass grafting performed through a small thoracotomy avoids sternotomy and may reduce postoperative pulmonary complications by improving respiratory mechanics and lowering systemic inflammatory response. This prospective observational comparative study aims to compare the incidence of postoperative pulmonary complications between patients undergoing off pump coronary artery bypass grafting and those undergoing minimally invasive off pump CABG. Postoperative pulmonary complications will be evaluated using validate scoring systems including the postoperative atelectasis severity score, CURB sixty five severity score, ventilator dependence severity score, pleural effusion severity score, and asthma severity score adapted for bronchospasm.
Given the significant impact of postoperative pulmonary complications on patient outcomes and health care costs, this study seeks to provide evidence on whether minimally invasive off pump CABG offers superior pulmonary outcomes, thereby guiding surgical decisions making in patients undergoing coronary revascularization. |