| CTRI Number |
CTRI/2026/04/107452 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measuring subclavian vein diameter in normal and deep breathing to predict drop in blood pressure in pregnant ladies scheduled for caesarean section after administering spinal anaesthesia |
|
Scientific Title of Study
|
Pre-anaesthetic ultrasonographic evaluation of subclavian vein diameter and collapsibility index during normal and deep breathing to predict the occurrence of hypotension after spinal anaesthesia in patients undergoing elective caesarean section : 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 |
Dr SHRINIDHI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
All India Institute Of Medical Sciences , Bathinda |
| Address |
Department of Anaesthesia , IPD block , AIIMS Bathinda , Mandi Dabwali road , Bathinda .
Bathinda
PUNJAB
151001
India |
| Phone |
8428451814 |
| Fax |
|
| Email |
shrinidhi1290@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JYOTI KANWAT |
| Designation |
Associate professor |
| Affiliation |
All India Institute Of Medical Sciences , Bathinda |
| Address |
Department of Anaesthesia , IPD block , AIIMS Bathinda , Mandi Dabwali road , Bathinda .
Bathinda
PUNJAB
151001
India |
| Phone |
8130269487 |
| Fax |
|
| Email |
gopikanwat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JYOTI KANWAT |
| Designation |
Associate professor |
| Affiliation |
All India Institute Of Medical Sciences , Bathinda |
| Address |
Department of Anaesthesia , IPD block , AIIMS Bathinda , Mandi Dabwali road , Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
8130269487 |
| Fax |
|
| Email |
gopikanwat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care , Bathinda , Punjab , 151001 , India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care , Bathinda , Punjab , 151001 , India |
| Address |
AIIMS Bathinda |
| 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 Shrinidhi |
All India Institute Of Medical Sciences , Bathinda |
Department of Anaesthesiology , IPD block ,AIIMS Bathinda, Mandi Dabwali road ,Bathinda , Punjab 151001
Bathinda
PUNJAB |
8428451814
shrinidhi1290@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Parturients coming under ASA II, III, planned for elective cesarean delivery under spinal anaesthesia.
2. Parturients of the cesarean section category III and above
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal of consent.
2. Any contraindications for spinal anaesthesia.
3. Patients with moderate to severe liver, respiratory, renal or cardiac dysfunction and who are hypotensive.
4. Patients who are at risk of intraoperative blood loss (placenta accreta or placenta previa).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the predictive ability of pre-anaesthetic measurement of subclavian vein diameter and collapsibility index during normal and deep breathing to predict post spinal hypotension in pregnant ladies scheduled for caesarean section |
To find the predictive ability of pre anaesthetic measurement of subclavian vein diameter and collapsibility index tom predict post spinal hypotension at every 1 minute until 5 minutes , and then every 2 minutes until cord clamping . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2026 |
| 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 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
|
This prospective study has been designed to compare the ultrasonographic evaluation of subclavian vein diameter and collapsibility index during normal and deep breathing to predict hypotension in pregnant patients undergoing elective caesarean section under spinal anaesthesia. We hypothesise that the Subclavian vein collapsibility index during normal and deep breathing is comparable for the prediction of hypotension after spinal anaesthesia in patients undergoing elective caesarean section.
|