| CTRI Number |
CTRI/2026/03/106922 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see whether suctioning through the breathing tube before chest opening can reduce lung lining injury in patients undergoing heart surgery. |
|
Scientific Title of Study
|
Effect of Endotracheal Suctioning During Disconnection of Ventilator on Pleural Space Violation in Median Sternotomy |
| 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 Aseem Gargava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of Anaesthesia
2nd Floor, Block 1, Hamidia Hospital
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Samdhani |
| Designation |
RMO Anaesthesia |
| Affiliation |
Gandhi Medical College |
| Address |
Department of Anaesthesia
2nd Floor, Block 1, Hamidia Hospital
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9606312961 |
| Fax |
|
| Email |
harshsamdhani97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aseem Gargava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of Anaesthesia
2nd Floor, Block 1, Hamidia Hospital
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Hamidia and associated Hospitals, Gandhi Medical College, Bhopal, Madhya Pradesh - 462001, India |
|
|
Primary Sponsor
|
| Name |
Dr Aseem Gargava |
| Address |
Department of Anaesthesia, Hamidia and associated Hospitals, Gandhi Medical College, Bhopal, Madhya Pradesh - 462001, India |
| 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 |
| Dr Aseem Gargava |
Hamidia Hospital |
2nd Floor, Block 1, Hamidia Hsopital
Bhopal
MADHYA PRADESH |
8860494714
aseemgargava@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: I089||Rheumatic multiple valve disease,unspecified, (2) ICD-10 Condition: I099||Rheumatic heart disease, unspecified, (3) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (4) ICD-10 Condition: I279||Pulmonary heart disease, unspecified, (5) ICD-10 Condition: I349||Nonrheumatic mitral valve disorder, unspecified, (6) ICD-10 Condition: I358||Other nonrheumatic aortic valve disorders, (7) ICD-10 Condition: I369||Nonrheumatic tricuspid valve disorder, unspecified, (8) ICD-10 Condition: I378||Other nonrheumatic pulmonary valvedisorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal suctioning during ventilator disconnection |
After induction of general anesthesia and before median sternotomy, the ventilator will be briefly disconnected and endotracheal suctioning will be performed to facilitate lung deflation. |
| Comparator Agent |
Ventilator disconnection without suctioning |
After induction of general anesthesia and before median sternotomy, the ventilator will be briefly disconnected without performing endotracheal suctioning. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–65 years undergoing elective cardiac surgery via median sternotomy under general anesthesia.
Patients with ASA physical status I–III.
Patients willing to participate and providing written informed consent. |
|
| ExclusionCriteria |
| Details |
Patient refusal,Patients with risk of aspiration,Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pleural space violation during median sternotomy in patients undergoing elective cardiac surgery. |
Incidence of pleural space violation during median sternotomy in patients undergoing elective cardiac surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in intraoperative hemodynamic parameters (SBP, DBP, MAP, heart rate). |
5 minutes before sternotomy, 3 minutes before sternotomy, 1 minute before sternotomy, 1 minute after sternotomy, and 1 minute after application of sternal retractor. |
| Intraoperative blood loss and chest drain output. |
Intraoperatively and within the first 24 hours postoperatively. |
| Changes in oxygen saturation (SpO2) during ventilator disconnection. |
During ventilator disconnection and immediately after sternotomy. |
| Incidence of postoperative pulmonary complications (atelectasis, pneumothorax, pleural effusion). |
Within 24–48 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
25/04/2026 |
| 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="0"
Months="4"
Days="10" |
|
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
|
Median sternotomy is the most common surgical approach used in cardiac surgery. During sternotomy there is a risk of accidental pleural space violation which may lead to postoperative pulmonary complications such as pneumothorax pleural effusion and prolonged chest drainage. Ventilator disconnection before sternotomy is commonly practiced to reduce lung volume and minimize pleural injury. Some anesthesiologists additionally perform endotracheal suctioning during this period to facilitate further lung deflation. However the effectiveness of this technique in reducing pleural space violation has not been adequately studied.
This prospective study aims to evaluate the effect of endotracheal suctioning during ventilator disconnection on the incidence of pleural space violation in patients undergoing elective cardiac surgery through median sternotomy. Patients aged 18 to 65 years undergoing elective cardiac surgery will be included in the study. Participants will be divided into two groups based on whether endotracheal suctioning is performed during ventilator disconnection before sternotomy. The incidence of pleural space violation will be recorded intraoperatively and compared between the two groups. Secondary outcomes such as hemodynamic parameters oxygen saturation intraoperative blood loss postoperative pulmonary complications and duration of ICU stay will also be evaluated.
The results of this study may help determine whether endotracheal suctioning during ventilator disconnection provides any additional benefit in reducing pleural injury during cardiac surgery. |