| CTRI Number |
CTRI/2024/11/076190 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to predict hypotension after spinal anesthesia in cesarean delivery by measuring capillary refill time , perfusion index and temperature gradient. |
|
Scientific Title of Study
|
Clinical comparative study of capillary refill time , perfusion index and temperature gradient as a predictor of post spinal hypotension in emergency lower segment caesarean section - an 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 |
Dr Sathiya S |
| Designation |
Post Graduate |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Kodagu institute of medical sciences, Madikeri
Kodagu institute of medical sciences, Madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
9486300401 |
| Fax |
|
| Email |
sathusandhu96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anesthesiology , Kodagu institute of medical sciences, Madikeri
Kodagu institute of medical sciences, Madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anesthesiology , Kodagu institute of medical sciences, Madikeri
Kodagu institute of medical sciences, Madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu institute of medical sciences , Madikeri -571201 |
|
|
Primary Sponsor
|
| Name |
Kodagu Institute of Medical Sciences |
| Address |
Kodagu Institute of Medical Sciences , Madikeri - 571201 |
| Type of Sponsor |
Government 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 Sathiya S |
Kodagu Institute of Medical Sciences and teaching hospital |
Operation theatre , MCH block,
Kodagu institute of medical sciences, Madikeri - 571201
Kodagu
KARNATAKA |
09486300401
sathusandhu96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Kodagu Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
capillary refill time |
Patients distal phalanx of index finger is compressed, observe for blanching ,after 15 seconds compression is released and note the time taken for the return of basal skin colour. |
| Comparator Agent |
Perfusion index |
Patient is connected to Masimo monitor ,by which perfusion index is measured and recorded |
| Comparator Agent |
Temperature gradient |
Temperature probe is connected to index finger and to the forearm between wrist and elbow , Gradient of these two values are noted. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
All patients undergoing emergency cesarean section under spinal anesthesia , ASA grade II E |
|
| ExclusionCriteria |
| Details |
1.Pregnancy induced hypertension , eclampsia , Antepartum haemorrhage , Gestational diabetes mellitus.
2.Twin pregnancy
3.Peripheral vascular disease
4.Finger amputation
5.Burnt injuries in finger
6.Patient with febrile illness
7.Failed spinal anesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
13/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
CLINICAL COMPARATIVE STUDY OF CAPILLARY REFILL TIME , PERFUSION INDEX AND TEMPERATURE GRADIENT AS A PREDICTOR OF POST SPINAL HYPOTENSION IN EMERGENCY LOWER SEGMENT CAESAREAN SECTION - AN OBSERVATIONAL STUDY. Patients will be selected based on inclusion and exclusion criteria . After shifting patient to preoperative room , Preanesthetic evaluation will be done with patient in left lateral position. Informed consent will be taken. Baseline vitals like HR , BP , saturation are recorded. With patient in left lateral position capillary refill time , perfusion index and temperature gradient are recorded and documented. Then shift the patient inside OT , Spinal anesthesia given with patient in left lateral position to achieve sensory level of T6. Vitals are monitored throughout the surgery - BP , HR , saturation , Temperature , urine output and perfusion index. Watch for hypotension. If h ypotension occurs it will be treated with fluids , ephedrine or phenylephrine. After the delivery of baby , inj.oxytocin will be given . |