| CTRI Number |
CTRI/2023/12/060878 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison and assessment of temperature monitoring between TEE probe temperature as core Temperature in cardiac surgery |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENTS OF TEMPERATURE MONITORING BETWEEN TRANSESOPHAGEAL ECHOCARDIOGRAPHY PROBE TEMPERATURE AND CORE TEMPERATURE IN CARDIAC SURGERY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar |
| Designation |
Professor and head of the department |
| Affiliation |
Banaras Hindu University |
| Address |
room no 510, CSSB Building, bhu varanasi
ims building, 2nd floor, room no 201, Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9005863817 |
| Fax |
|
| Email |
sanjaykr33@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar |
| Designation |
Professor and head of the department |
| Affiliation |
Banaras Hindu University |
| Address |
room no 510, 5th floor ctvs department, cssb building, bhu, varanasi
room no 201, 2nd floor ctvs department, ims building, bhu, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9005863817 |
| Fax |
|
| Email |
sanjaykr33@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar |
| Designation |
Professor and head of the department |
| Affiliation |
Banaras Hindu University |
| Address |
room no 510, 5th floor ctvs department, cssb building, bhu, varanasi
room no 201, 2nd floor ctvs department, ims building, bhu, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9005863817 |
| Fax |
|
| Email |
sanjaykr33@hotmail.com |
|
|
Source of Monetary or Material Support
|
| CSSB, SIR SUNDERLAL HOSPITAL, Banaras Hindu University, varanasi- U.P. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 Akhalesh Maurya |
Institute of medical sciences |
room no 201, 2nd floor, department of ctvs,Ims building, bhu varanasi
Varanasi
UTTAR PRADESH |
08898410785
mauryaakhalesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I088||Other rheumatic multiple valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
This study will be performed on 60 adults of either sex in the range of 20 to 70yrs of age with weight more than 30kg undergoing cardiac surgery with use of cardiopulmonary bypass. |
|
| ExclusionCriteria |
| Details |
: This study will not be perfmed
1. All emergency cases.
2. Patients having oral or rectal cancer
3. Cold blood agglutination
4. Patients having fever.
5. Patients are having systemic infection
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Temperatures monitoring during cardiac surgery is useful with TEE or its showing false temperature. Relationship with brain temperature |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship of TTE Temperature with brain temperature during surgery |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
background:- as tee is placed in every cardiac surgery and temperature probe is also their atleast from 2 sites, which also leads to infection in the many of the patients
purpose:- So main purpose is to determine TEE temperature monitoring is reliable in adult group of patients or not. |