| CTRI Number |
CTRI/2024/10/075170 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Carotid Doppler Ultrasound Parameters as a predictor of hypotension after induction of general anaesthesia in elective surgeries. |
|
Scientific Title of Study
|
Changes in Carotid Artery Corrected Flow Time following a simulated end-inspiratory occlusion maneuver as a predictor of hypotension after induction of general anaesthesia in elective surgeries - 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 Bhavna Gupta |
| Designation |
Associate Professor |
| Affiliation |
All Inida Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesia, Level 6,
All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh , Uttarkashi, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Depart Of Anaesthesia, Level 6
All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh, Uttarkashi, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Biswakarma |
| Designation |
Post Graduate Resident |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesia, Level 6, All India Institute of Medical Sciences Rishikesh, Veerbhadra Marg, Rishikesh, Uttarkashi, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9749001458 |
| Fax |
|
| Email |
jaykrmkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh
Veer Bhadra Marg, Rishikesh, Uttarakhand, India
Pin - 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Veerbhadra Marg, Rishikesh, Uttarakhand 249203 |
| 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 Kunal Biswakarma |
All India Institute of Medical Sciences Rishikesh |
Department of Anaesthesia, Level 6, Academic Block, Veerbhadra Marg, Rishikesh, Uttarakhand - 249203
Dehradun
UTTARANCHAL |
9749001458
jaykrmkr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTIONAL ETHICS COMMITTEE |
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 |
Patients Undergoing Elective Surgeries
Patients adherent to routine fasting protocols before surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe hypertension or SBP more than 160mmHg or hemodynamic instability.
2. Patients with baseline MAP less than 70mmHg or SBP less than 90mmHg.
3. Patients with history of Atherosclerosis, arrhythmia, symptomatic cardiac patients and major valvular heart disease.
4. Patients with Diabetes having autonomic neur.
5. Patients with severe pulmonary disease, or respiratory insufficiency or features of Cor Pulmonale.
6. Hypertensive patients on ACE inhibitors or Angiotensin receptor blockers before surgery.
7. Chronic Kidney Disease patients with AV fistula or on dialysis.
8. Patients on prolonged fasting.
9. Patients failing to comply with simulated end inspiraotry occlusion maneuver.
10. Patients in which getting clear and effective USG images and measurements are not possible.
11. Patients with recent history of cerebrovascular accidents or transient ischemic attacks.
12. Patients with significant carotid artery stenosis of more than 50 percent or other carotid abnormalities detected on preoperative imaging.
13. Patients with history of recent myocardial infarction or unstable angina.
14. Patients with a history of significant bleeding disorders or active bleeding at the time of surgery.
15. Patient with history of severe neurological disorders affecting autonomic function such as parkinsons disease or multiple system atrophy.
16. Patients with history of severe anaemia with hemoglobin less than 8, or requiring ongoing blood tranfusions.
17. Patients with history of severe liver disease or dysfunction.
18. Patients with history of recent major surgery or trauma within the last month.
19. Patients with history of severe cognitive impair psychiatric disorders that may affect their ability to participate in the study.
20. Patients with history of significant vasculitis or vascular abnormalities affecting carotid arteries.
21. Patients with history of recent respiratory tract infections or pneumonia within the last two weeks.
22. Patients with known pregnancy or breastfeeding at the time of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Baseline Carotid Flow Time, Baseline Corrected Carotid Flow time, Carotid flow time and corrected carotid flow time following end inspiratory occlusion maneuver, change in corrected carotid flow time following end inspiratory occlusion maneuver.
NIBP measurements of SBP, DBP and MAP at different time points after endotracheal intubation. |
T0 - Baseline
Ts - Following End inspiratory occlusion maneuver
T1 - 3 minutes after endotracheal Intubation
T2 - 5 minutes after endotracheal intubation
T3 - 7 minutes after endotracheal intubation
T4 - 9 minutes after endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Carotid Peak systolic velocity- Baseline and Following End inspiratory occlusion maneuver, change in carotid peak systolic velocity following end inspiratory occlusion maneuver. |
T0 - Baseline
Ts - Following End inspiratory occlusion maneuver
T1 - 3 minutes after endotracheal Intubation
T2 - 5 minutes after endotracheal intubation
T3 - 7 minutes after endotracheal intubation
T4 - 9 minutes after endotracheal intubation. |
| Hemodynamic parameters such as Heart Rate , SBP, DBP, MAP and SPO2 baseline and following end inspiratory occlusion maneuver, change in hemodynamic parameters following end inspiratory occlusion maneuver. |
T0 - Baseline
Ts - Following End inspiratory occlusion maneuver
T1 - 3 minutes after endotracheal Intubation
T2 - 5 minutes after endotracheal intubation
T3 - 7 minutes after endotracheal intubation
T4 - 9 minutes after endotracheal intubation. |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
25/10/2024 |
| 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="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
|
Hypotension after induction of general anaesthesia and intra-operative hypotension is common and may be associated with fatal outcomes such as end organ damage and myocardial ischemia. This study is a prospective observational study conducted in AIIMS Rishikesh and it aims to determine the utility of the change in common carotid artery corrected flow time following a simulated end inspiratory occlusion maneuver for prediction of hypotension after induction of general anaesthesia. The study will include patients aged 18-65 years of age undergoing elective surgeries under general anaesthesia. The outcome variables that will be recorded are baseline and post simulated inspiratory occlusion maneuver corrected carotid artery flow time and carotid peak systolic velocity using carotid ultrasonography and hemodynamic parameters such as Heart Rate, Blood Pressure and Oxygen saturation at different time points after endotracheal intubation. Statistical analysis will done using statistical software SPSS 25.0 and statistical significance will be set at p<0.05. Ethics Approval for the study was taken from Institutional Ethics Committee from AIIMS Rishikesh. |