| CTRI Number |
CTRI/2020/10/028228 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Esophageal echocardiography probe as a temperature monitor in cardiac surgery |
|
Scientific Title of Study
|
Performance of the transesophageal echocardiography probe as an esophageal temperature monitor in patients undergoing cardiac surgery with cardiopulmonary bypass: A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Satyajeet Misra |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar |
| 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 Satyajeet Misra |
AIIMS Bhubaneswar |
Room No 409, Fourth floor
Academic Block
Khordha
ORISSA |
9438884048
misrasatyajeet@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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing cardiac surgery under cardiopulmonary bypass will be included in this study |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to TEE probe will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of TEE probe as an oesophageal temperature monitor |
Intraoperative- 5, 10,15, 20 and 30 minutes after cooling on CPB and 5, 10, 15, 20, and 30 minutes after rewarming |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2020 |
| Date of Study Completion (India) |
22/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Eur J Cardiothorac Surg 2023; doi: 10.1093/ejcts/ezad242 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Neurological complications are common in patients undergoing cardiac surgery and range from subtle cognitive decline to stroke. Hypothermia is used as a neuroprotective strategy but inadequate cooling or excessive rewarming on cardiopulmonary bypass often leads to inadequate neuroprotection. A variety of temperature monitoring sites are used but each lags behind true brain temperature. Transesophageal echocardiography (TEE) is used for monitoring of the heart and great vessels during the conduct of cardiac surgery. TEE probe has a thermistor at its tip and is very sensitive to track tissue temperature changes since it is designed to protect the tissues from injury. The TEE probe operates within temperature range of 18-42 degrees centigrade and shunts down below and above these temperatures. The TEE probe may thus be able to track core temperature changes earlier than the nasopharyngeal temperature probe. Thus, the aim of this study will be to compare the performance of the TEE probe as an esophageal temperature probe with the nasopharyngeal temperature probe and the arterial outlet temperature probe. |