| CTRI Number |
CTRI/2025/10/096386 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
How inserting and moving a heart ultrasound probe through the food pipe affects the pressure of breathing tube in adults undergoing heart surgery on heart lung machine |
|
Scientific Title of Study
|
Effect of transesophageal echocardiographic probe placement and manipulation on endotracheal cuff pressure in adult patients undergoing cardiac surgery on cardiopulmonary bypass |
| 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 Saumyaa Vishwaani |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
9306556615 |
| Fax |
|
| Email |
saumyaavishwaani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ira Balakrishnan M |
| Designation |
Associate Professor |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
7838867927 |
| Fax |
|
| Email |
irabala82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ira Balakrishnan M |
| Designation |
Associate Professor |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India |
| Phone |
7838867927 |
| Fax |
|
| Email |
irabala82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College and Safdarjung Hospital,ansari nagar, South Delhi, Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Ansari nagar east, New Delhi, Delhi, India, 110029 |
| 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 Saumyaa Vishwaani |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and intensive care, 1st floor Super Speciality Block, Safdarjung Hospital, Ansari Nagar east, New Delhi 110029
New Delhi
DELHI |
9306556615
saumyaavishwaani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhaman Mahavir Medical College and Safdarjung Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18-65 years fulfilling the criteria of American Society of Anesthiolologists grade 2 and 3 undergoing elective cardiac surgery on cardiopulmonary bypass under mild to moderate hypothermia |
|
| ExclusionCriteria |
| Details |
1. Patients with difficult airway contraindicating TEE probe placement
2. Patients with preexisting tracheal pathology
3. Patients with oesophageal pathology or previous oesophageal surgeries contraindicating probe insertion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Endotracheal tube cuff pressure, mean arterial pressure and tracheal perfusion pressure |
T0-before TEE insertion baseline , T1-during TEE insertion ,T2- 5min after TEE probe insertion,T3-during TEE examination,T4- after completing TEE examination ,T5- on CPB at maximum hypothermia, T6- after complete rewarming and T7-while removing the probe |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak airway pressure & mean airway pressure |
T0-before TEE insertion baseline , T1-during TEE insertion ,T2- 5min after TEE probe insertion,T3-during TEE examination,T4- after completing TEE examination ,T5- on CPB at maximum hypothermia, T6- after complete rewarming & T7-while removing the probe |
| Hemofiltration volume on CPB, hemodilution , hematocrit and electrolyte changes |
|
| Incidence of postoperative complications like sore throat, hoarseness of voice, stridor or reintubation |
Postoperatively |
|
|
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)
|
02/11/2025 |
| 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 Yet Recruiting |
| 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 study is a prospective observational study to determine effects of transesophageal echocardiographic probe insertion placement and its manipulation on endotracheal cuff pressure in adults aged 18-65 years who are undergoing cardiac surgery on cardiopulmonary bypass. The primary outcome is measuring endotracheal tube cuff pressure, mean arterial pressure and tracheal perfusion pressure before transesophageal echocardiographic probe insertion, during insertion, 5 mins after transesophageal echocardiographic probe insertion, during transesophageal echocardiographic probe examination, after transesophageal echocardiographic probe examination, on cardiopulmonary bypass at maximal hypothermia, after rewarming and while probe removal. |