| CTRI Number |
CTRI/2024/07/071249 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Perfusion index can be used to identify hypotension early in patients undergoing lower segment cesarean sections |
|
Scientific Title of Study
|
Evaluation of real time perfusion index as an early indicator for hypotension in a lower segment caesarean section 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 |
Nanthitha Sri |
| Designation |
Student |
| Affiliation |
Manipal college of health professions MAHE Manipal |
| Address |
Manipal college of Health professions , Anaesthesia and Operation theatre technology Programme , MAHE, Manipal , Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9566080137 |
| Fax |
|
| Email |
nanthitha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahesh nayak |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college and hospital MAHE Manipal |
| Address |
Kasturba medical college and hospital, Department of Anaesthesiology , MAHE, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9632898777 |
| Fax |
|
| Email |
nayak.mahesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nanthitha Sri |
| Designation |
Student |
| Affiliation |
Manipal college of health professions, MAHE, Manipal |
| Address |
Manipal college of health professions, Anaesthesia and Operation theatre technology Programme, MAHE, Manipal,
Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9566080137 |
| Fax |
|
| Email |
nanthitha.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and hospital MAHE tiger circle road Manipal Udupi Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Nanthitha Sri |
| Address |
Anaesthesia and operation theatre technology MCHP MAHE Manipal Udupi Karnataka India 576104 |
| 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 Mahesh nayak |
Kasturba medical college and hospital |
Department of Anaesthesiology Operation theatre
Udupi
KARNATAKA |
9632898777
nayak.mahesh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Parturient undergoing elective LSCS
Patients with ASA â…¡ and â…¢ Grading
|
|
| ExclusionCriteria |
| Details |
LSCS done under general anaesthesia Twin gestation
Pregnancy induced hypertension Pre-eclampsia
Emergency LSCS Chronic hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perfusion Index and Perfusion ratio to predict hypotension early when compared it with NIBP |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
04/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
|
Hypotension can be monitored non-invasively by
the NIBP. For real-time measurement of NIBP, Invasive measurements can be done
using arterial blood pressure, but they are not cost-efficient. In modern
medicine, the perfusion index is faster at predicting hypotension when compared
with non-invasive blood pressure measurement. |