| CTRI Number |
CTRI/2025/12/098579 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using an ultrasound scan before elective surgery to see if a patient might have low blood pressure when put under general anaesthesia. |
|
Scientific Title of Study
|
Preoperative Ultrasonographic Evaluation of Subclavian Vein and Inferior Vena Cava for Predicting Hypotension Associated with Induction of General Anaesthesia |
| 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 Jyoti Pathania |
| Designation |
Professor and guide |
| Affiliation |
Rohilkhand Medical College. Bareilly |
| Address |
Room no. 25
Ac girls hostel
Rohilkhand Medical College
Pilibhit bypass road
Bareilly
Pincode- 243006
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9418120659 |
| Fax |
|
| Email |
pathaniajyoti7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saumya Pathak |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College. Bareilly |
| Address |
2062-B
Department of Anesthesia
Rohilkhand Medical College
Pilibhit bypass road
Bareilly
Pincode- 243006
Bareilly UTTAR PRADESH 243006 India |
| Phone |
7860383892 |
| Fax |
|
| Email |
saumyapathak81@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saumya Pathak |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College. Bareilly |
| Address |
2062-B
Department of Anesthesia
Rohilkhand Medical College
Pilibhit bypass road
Bareilly
Pincode-243006
Bareilly UTTAR PRADESH 243006 India |
| Phone |
7860383892 |
| Fax |
|
| Email |
saumyapathak81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and hospital
Ohilibhit bypass road
Bareilly |
|
|
Primary Sponsor
|
| Name |
Dr Saumya Pathak |
| Address |
Room no. 25
Ac girls hostel
Rohilkhand Medical College
Pilibhit bypass road
Bareilly
Pincode- 243006 |
| 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 Saumya Pathak |
Rohilkhand Medical College |
Rohilkhand Medical College
Pilibhit bypass road
Bareilly
UP
243006
India Bareilly UTTAR PRADESH |
07860383892
saumyapathak81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe rmch barielly up |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Grade 1 2 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R688||Other general symptoms and signs, (3) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. To assess collapsibility indices of IVC and SCV in the patients.
2. To determine the diagnostic accuracy of SCV-CI and IVC-CI in predicting post
induction hypotension.
3. To study the proportions of patients experiencing PIH.
4. To corelate other demographic factors with PIH in patients |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Patients with local infection, surgical scars, or deformities in the chest or
abdominal region
3. Patients receiving vasopressors or significant fluid resuscitation prior to
induction
4. Patients with arrhythmias such as atrial fibrillation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess collapsibility indices of IVC and SCV in the patients.
2. To determine the diagnostic accuracy of SCV-CI and IVC-CI in predicting post
induction hypotension.
3. To study the proportions of patients experiencing PIH.
4. To corelate other demographic factors with PIH in patients |
1. To assess collapsibility indices of IVC and SCV in the patients.
2. To determine the diagnostic accuracy of SCV-CI and IVC-CI in predicting post
induction hypotension.
3. To study the proportions of patients experiencing PIH.
4. To corelate other demographic factors with PIH in patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
20/12/2025 |
| 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="1" Months="0" 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
|
in this study the patients undergoing the procedure in the general anesthesia are evaluated in the preoperative room for ivc and scv collapsibilty and then in the operation theatre room for about 18 minutes , out of which thhe first 4 minutes are till the induction and then the rest 14 minutes post induction, reading taken every 2 minutes post induction.
this show the changes in the hemodynamic parameters of the patient depending upon the collapsisbitly index taken in preoperative room |