| CTRI Number |
CTRI/2024/10/074826 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preoperative ultrasound-guided subclavian diameter changes assessment by passive leg raising for assessing the occurrence of fall in blood pressure after general anaesthesia in patients with head and neck malignancies |
|
Scientific Title of Study
|
Preoperative ultrasound guided estimation of subclavian vein diameter changes by passive leg rising to assess the incidence of post-induction hypotension after General anaesthesia in patients of head and neck malignancies: 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 Roopesh R |
| Designation |
Senior resident( DM Onco-Anaesthesia) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Onco-Anaesthesiology and Palliative medicine,
Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9020203379 |
| Fax |
|
| Email |
roopeshramesh2011@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anuja Pandit |
| Designation |
Associate Professor |
| Affiliation |
National Cancer Institute (NCI)- AIIMS New Delhi |
| Address |
National Cancer Institute (NCI)- AIIMS, JHAJJAR, HARYANA
Jhajjar HARYANA 124105 India |
| Phone |
9710030457 |
| Fax |
|
| Email |
anujapandit2412@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopesh R |
| Designation |
Senior resident( DM Onco-Anaesthesia) |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Onco-Anaesthesiology and Palliative medicine,
Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9020203379 |
| Fax |
|
| Email |
roopeshramesh2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-Anaesthesiology and Palliative medicine,
Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Dr BRAIRCH AIIMS Campus Ansari Nagar East New Delhi 110029 |
| 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 Roopesh R |
All India Institute of Medical Sciences New Delhi |
Operation theatre 6th floor, Dr BRAIRCH AIIMS Campus Ansari Nagar East New DElhi 110029 New Delhi DELHI |
9020203379
roopeshramesh2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
passive leg raising |
passive leg raising upto 45 degrees for 90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1,Patients with age between18 to 70 years and American Society of Anaesthesiologists (ASA) Physical Status class I, II and III:
2,Patients undergoing elective head and neck oncological malignancies
|
|
| ExclusionCriteria |
| Details |
patient refusal
patients belonging to ASA 4 and 5
severe renal, hepatic, cardiac failure
signs of fluid overload before anaesthesia |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether the ultrasonographic measurement of Subclavian vein diameter changes by passive leg rising will be able to predict hypotension after induction of general anaesthesia in patients of head and neck malignancies. |
up to 10 minutes after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the predictive ability of subclavian vein collapsibility index for the incidence of post-induction hypotension in patients of head and neck malignancies |
upto 10 minutes after induction of anaesthesia |
| To assess the predictive maximum diameter of subclavian vein in passive leg rising position for the incidence of post-induction hypotension in patients of head and neck malignancies |
upto 10 minutes after induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="152" Sample Size from India="152"
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)
|
20/10/2024 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Postinduction hypotension can occur during the early phase of anesthesia, typically within 20 minutes after the induction of general anesthesia. Several factors contribute to postinduction hypotension. General anesthetic agents can cause vasodilation, leading to decreased systemic vascular resistance and subsequent hypotension.Reduced blood volume due to inadequate fluid status or preoperative fasting can contribute to the same patient characteristics like age, comorbidities, and medications the patient is taking all may have an effect.Prolonged hypotension during surgery can have significant consequences for patients. Prolonged low blood pressure can impair perfusion to vital organs and may lead to myocardial injury, acute kidney injury, cerebral ischemia etc. So it is of paramount importance to identify the risk groups prior to induction and manage the hypotension judiciously. Pre-induction ultrasonography of IJV was used to predict post-induction hypotension and SCV collapsibility index in deep inspiration has been shown to predict hypotension after induction of GA. We hypothesize that the
subclavian vein diameter changes induced by passive leg rising can be used to
estimate intravascular fluid status and can be an indicator of incidence of
hypotension after general anaesthesia. Therefore we aim to evaluate the the
predictive power of ultrasound guided diameter changes of subclavian vein in
the spontaneous breathing PLR position.for post induction hypotension
|