| CTRI Number |
CTRI/2024/04/066262 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
To estimate core body temperature by comparing skin temperature over carotid artery with nasopharyngeal temperature |
|
Scientific Title of Study
|
Comparison of skin temperature over carotid artery to nasopharyngeal temperature for temperature monitoring in adults under general anaesthesia for abdominal surgeries - a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abelash |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and hospital |
| Address |
Department of anaesthesiology, No 55, resident quarters , sri Manakula vinayagar medical college and hospital , Puducherry, India- 605107
Department of anaesthesiology, No 55, resident quarters , sri Manakula vinayagar medical college and hospital , Puducherry, India- 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9843769098 |
| Fax |
|
| Email |
abelash10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suneeth P Lazarus |
| Designation |
HOD |
| Affiliation |
Sri manakuka vinayagr medical college and hospital |
| Address |
Department of anaesthesiology , room no 107, first floor, Sri Manakula Vinayagar medical college and hospital, puducherry
Department of anaesthesiology , room no 107, first floor, Sri Manakula Vinayagar medical college and hospital, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
Lazarus.suneeth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneeth P Lazarus |
| Designation |
HOD |
| Affiliation |
Sri manakuka vinayagr medical college and hospital |
| Address |
Department of anaesthesiology , room no 107, first floor, Sri Manakula Vinayagar medical college and hospital, puducherry
Department of anaesthesiology , room no 107, first floor, Sri Manakula Vinayagar medical college and hospital, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
Lazarus.suneeth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula vinayagar medical college and hospital , kalitheerthalkuppam, Madagadipet, Puducherry, India- 605107 |
|
|
Primary Sponsor
|
| Name |
Abelash |
| Address |
2/9,School street, Mitta Mandagapattu, villupuram, Tamil nadu - 605106 |
| 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 Abelash |
Sri Manakula vinayagar medical college and hospital |
Room no 107, Department of anaesthesiology, first floor, Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry - 605107
Pondicherry
PONDICHERRY |
9843769098
abelash10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2
Patient willing to sign informed consent
Patient posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnancy
Patient with suspected nasal deformities and nasal injuries
Patient with known carotid pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) skin temperature over carotid artery |
1) at baseline
2) at 2 weeks
3) at 4 weeks
4) at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) nasopharyngeal temperature |
0mins
15mins
30mins
45mins
60mins |
|
|
Target Sample Size
|
Total Sample Size="109"
Sample Size from India="109"
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)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| 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
|
Anaesthesia and surgery significantly affects the internal thermoregulation of the human body. Therefore, temperature monitoring is one of the mandatory parameters to be monitored during anaesthesia and to take appropriate measurements to avoid large changes in body temperature. Ideally, temperature monitoring should be the measurement of the core temperature. The core thermal compartment is composed of the highly perfused tissues whose temperature is uniform and high compared with the rest of the body. This core temperature monitoring is done at several sites including nasopharyngeal, oesophageal, tympanic, and pulmonary artery which are mostly invasive in nature. Both nasopharyngeal and oesophageal temperatures are favored as primary indicators of intraoperative thermal status due to their proximity to the internal carotid artery and great vessels and heart, respectively. The peripheral sites of temperature monitoring like axillary, forehead, and abdominal skin showed poor reliability with the core temperature monitoring sites during intraoperative temperature monitoring. |