| CTRI Number |
CTRI/2025/08/092284 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How Flow of blood in the Wrist Changes After putting a Tube Through the Mouth into the lungs During Anesthesia: A Study Comparing People With and Without High Blood Pressure |
|
Scientific Title of Study
|
A Prospective Observational Study to Compare the Sympathetic Vasomotor Response of the Radial Artery Using Resistive Index and Pulsatility Index Following Endotracheal Intubation in Hypertensive vs. Normotensive Patients |
| 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 Derlin Thomas |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur, Kerala, India |
| Address |
Dept. of Anesthesiology,
Amala Institute of Medical Sciences, Thrissur, Kerala, India
Amala Institute of Medical Sciences, Thrissur, Kerala, India
Thrissur
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Derlin Thomas |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur, Kerala, India |
| Address |
Dept. of Anesthesiology,
Amala Institute of Medical Sciences, Thrissur, Kerala, India
Amala Institute of Medical Sciences, Thrissur, Kerala, India
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Derlin Thomas |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur, Kerala, India |
| Address |
Dept. of Anesthesiology,
Amala Institute of Medical Sciences, Thrissur, Kerala, India
Amala Institute of Medical Sciences, Thrissur, Kerala, India
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences, Amalanagar, Thrissur, Kerala, India 680555 |
|
|
Primary Sponsor
|
| Name |
Amala Institute of Medical Sciences, Thrissur, Kerala, India |
| Address |
Amala Institute of Medical Sciences, Thrissur, Kerala, India 680555 |
| Type of Sponsor |
Private 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 Derlin Thomas |
Amala Institute of Medical Sciences |
Amala Institute of Medical Sciences,Amalanagar, Thrissur, Kerala, India 680555
Thrissur
KERALA |
9447768944
derlin.t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Groups
Age 18–65 years
American Society of Anesthesiologists (ASA) physical status I–III
Scheduled for elective surgery under general anesthesia with endotracheal intubation
2. Hypertensive Group
Diagnosed hypertension (SBP more than 140 mmHg or DBP more than 90 mmHg or on antihypertensive medication)
3. Normotensive Group
No history of hypertension (SBP less than or equal to 140 mmHg and DBP less than or equal to 90 mmHg)
|
|
| ExclusionCriteria |
| Details |
1. Inability to provide informed consent
2. Patients with significant arrhythmias or other cardiovascular instabilities.
3. Patients with peripheral vascular disease affecting the upper limbs.
4. Patients on medications that could significantly alter vascular tone (like high-dose vasodilators and inotropes).
5. Pregnant patients.
6. Inability to obtain clear Doppler signals from the radial artery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare changes in RI and PI of the radial artery before and after endotracheal intubation between hypertensive and normotensive patients |
at the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the correlation between blood pressure changes and Doppler ultrasound parameters.
2. To evaluate the time course of vascular response following intubation.
3. To determine if hypertensive patients exhibit greater vasomotor instability post-intubation compared to normotensive patients.
|
at the end of 12 months |
|
|
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)
|
25/08/2025 |
| 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 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 observational cohort study aims to compare the sympathetic vasomotor response of the radial artery to endotracheal intubation in hypertensive and normotensive patients, using Doppler-derived resistive index (RI) and pulsatility index (PI). A total of 80 adult patients undergoing elective surgery under general anaesthesia will be enrolled. RI and PI will be measured at baseline and at 1, 3, and 5 minutes post-intubation. Haemodynamic parameters will also be recorded. The study evaluates whether hypertensive patients exhibit an exaggerated vascular response. Results may assist in optimising perioperative care and understanding vascular reactivity differences between hypertensive and normotensive patients. |