| CTRI Number |
CTRI/2025/02/080284 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF CAROTID ARTERY SURFACE TEMPERARURE VS AXILLARY SURFACE TEMPERATURE IN CHILDREN UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA
|
|
Scientific Title of Study
|
COMPARISON OF CAROTID ARTERY SURFACE TEMPERARURE VS AXILLARY SURFACE TEMPERATURE IN CHILDREN UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA,KEEPING NASOPHARYNGEAL TEMPERATURE AS GOLD STANDARD |
| 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 Sonal Khatavkar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Dr DY PATIL Vidyapeeth Hospital & Research Centre, Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SONAL KHATAVAKR |
| Designation |
Postgraduate student |
| Affiliation |
|
| Address |
Dr DY PATIL Vidyapeeth Hospital & Research Centre, Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Erry |
| Designation |
Postgraduate student |
| Affiliation |
DR DY PATIL VIDYAPEETH, PUNE |
| Address |
Dr DY PATIL Vidyapeeth Hospital & Research Centre, Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9971098871 |
| Fax |
|
| Email |
erryash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th floor, Hi-tech building, Dr. D.Y. Medical college, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India Pinncode-411018 |
|
|
Primary Sponsor
|
| Name |
DR ASHISH ERRY |
| Address |
Department of Anaesthesia, 5th floor, Hi-tech building, DR DY PATIL MEDICAL COLLEGE, HOSPITAL and RESEARCH CENTRE, SANT TUKARAM NAGAR, PIMPRI, PUNE, MAHARASHTRA 411018,INDIA |
| Type of Sponsor |
Private 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 ASHISH ERRY |
DR DY PATIL MEDICAL COLLEGE HOSPITAL SANT TUKARAM NAGAR PIMRPI PUNE MAHARASHTRA 411018 |
DR DY PATIL MEDICAL COLLEGE HOSPITAL and RESEARCH CENTRE SANT TUKARAM NAGAR PIMRPI PUNE 411018
DHANWANTRI BOYS HOSTEL,NEAR PERFECT GYM,DR DY PATIL MEDICAL COLLEGE PUNE MAHARASHTRA 411018
Pune
MAHARASHTRA |
9971098871
erryash@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS SUB-COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified, (2) ICD-10 Condition: K223||Perforation of esophagus, (3) ICD-10 Condition: N259||Disorder resulting from impaired renal tubular function, unspecified, (4) ICD-10 Condition: E169||Disorder of pancreatic internal secretion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carotid artery surface temperature |
Axillary surface temperature |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric patients 1-6 years of age
2. Elective surgeries of more than 2 hours
3. ASA(American Society of Anesthesiologists)1&2 |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate
2. Neonates
3. Patients undergoing emergency surgeries
4. Patients having coagulopathies, bleeding tendencies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate correction factor between axillary surface temperature & carotid artery surface temperature |
Evaluating correction factor between axillary surface temperature & carotid artery surface temperature |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate effects of changes in 1 degree celsius change in core temperature on mean artrial pressure, systolic blood pressure, diastolic blood pressure & heart rate |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
16/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an observational study to evaluate correction factor between axillary surface temperature & carotid artery surface temperature with nasopharyngeal as standard core temperature ,also to evaluate effects of 1 degree celsius change in core temperature on MAP, systolic blood pressure, diastolic blood pressure & heart rate. |