| CTRI Number |
CTRI/2023/09/057247 [Registered on: 05/09/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observation prospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the changes between inner body temperature and blood circulation of the finger during general anesthesia |
|
Scientific Title of Study
|
:A prospective observational study of the relationship between peripheral perfusion index and core body temperature during general anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya A |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anesthesiology and Critical Care,
4th floor, A Block Operation theatre,
All India Institute of Medical Sciences, Great Eastern Road, Tatibandh,
Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
6374956762 |
| Fax |
|
| Email |
fantasydivya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Vitthal Kalbande |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anesthesiology and Critical Care,
4th floor, A Block Operation theatre,
All India Institute of Medical Sciences, Great Eastern Road, Tatibandh,
Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya A |
| Designation |
Post graduate junior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anesthesiology and Critical Care,
4th floor, A Block Operation theatre,
All India Institute of Medical Sciences, Great Eastern Road, Tatibandh,
Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
06374956762 |
| Fax |
|
| Email |
fantasydivya@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
Department of Anesthesiology and Critical Care,
4th floor, A Block Operation theatre,
All India Institute of Medical Sciences, Great Eastern Road, Tatibandh,
Raipur. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya A |
All India Institute of Medical Sciences |
Department of Anesthesiology and critical care,
4th floor, A Block Operation theatre,
All India Institute of Medical Sciences, Great Eastern Road, Tatibandh,
Raipur.
Raipur
CHHATTISGARH |
06374956762
fantasydivya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS: 1 or 2
BMI: 18.5- 24.9 KG/M2
BSA: 1.6-1.9 M2
Surgeries lasting for more than 1 hour and less than 4 hours |
|
| ExclusionCriteria |
| Details |
Patient refusal
Peripheral vascular disease
Comorbidities like diabetes or hypertension
History of acute vascular events like TIA, stroke, coronary artery disease
Chronic smoker
Surgeries requiring intraoperative blood transfusion
Surgeries with increased third space loss
Surgeries requiring tourniquet
Others like fever, hyperthyroidism, malignant hyperthermia, sepsis, nail abnormalities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the relation between peripheral perfusion index & core body temperature |
Baseline, at induction of anesthesia and every 15 mins thereafter till 1 hour after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for the latency between changes in core temperature & perfusion index |
Baseline, at induction of anesthesia & every 15 mins thereafter till 1 hour after extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [fantasydivya@gmail.com].
- For how long will this data be available start date provided 20-03-2024 and end date provided 20-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to study the relationship between the peripheral perfusion index and the core body temperature using an infrared tympanic membrane thermometer. |