| CTRI Number |
CTRI/2024/09/073847 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Use Of Ultrasound For Prediction Of Postspinal Hypotension In Geriatric Patients Posted For Lower Limb Surgeries |
|
Scientific Title of Study
|
THE USE OF IJV COLLAPSIBILITY INDEX (IJVCI) FOR PREDICTION OF POSTSPINAL HYPOTENSION IN GERIATRIC PATIENTS POSTED FOR LOWER LIMB SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirandeep |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
Maharishi Markandeshwar Institute of Medical Sciences and
Research Centre, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7527023600 |
| Fax |
01731274495 |
| Email |
kirandeep9150@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kirandeep |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
Maharishi Markandeshwar Institute of Medical Sciences and
Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7527023600 |
| Fax |
01731274495 |
| Email |
kirandeep9150@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kirandeep |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
Maharishi Markandeshwar Institute of Medical Sciences and
Research Centre, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7527023600 |
| Fax |
01731274495 |
| Email |
kirandeep9150@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, Haryana, India.
Pincode : 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Maharishi Markandeshwar
(Deemed to be University),
Ambala-Yamunanagar Highway, Mullana-Ambala (Haryana), India (133207) |
| 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 Kirandeep |
Maharishi Markandeshwar Institute of Medical Sciences and Research, Ambala |
HOD Room, Department of Anaesthesia, OT Complex Division, Maharishi Markandeshwar (Deemed to be University), Ambala-Yamunanagar Highway, Mullana-Ambala, 133207
Ambala
HARYANA |
7527023600
01731274495
kirandeep9150@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee M.M.Institute of Medical Sciences & Research, Mullana (Ambala) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study population will consist of patients of either gender, aged 50 years and above; ASA-PS 1, 2, and 3; BMI ≥ 20 to ≤ 30 kg/m2; planned for elective lower limb surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate; ASA-PS 4 and above; history of severe cardiovascular, renal disease and hepatic disorders; pregnancy; obesity; emergency cases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Internal Jugular Vein collapsibility index to predict post spinal hypotension. |
Baseline, 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 15 minutes and 20 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
03/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kirandeep9150@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 11-08-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Subarachnoid block performed for lower limb surgeries in geriatric population is commonly associated with hypotension, which can have adverse health outcomes. Internal Jugular Vein being an easily accessible structure by ultrasound, can be used to estimate intravascular volume status prior to performing subarachnoid block and hence prevention of post-spinal hypotension by optimising intravascular volume. Studies presently available for IJV collapsibility index as a tool to assess post-spinal hypotension are focussed on pregnant population. The physiological changes of pregnancy differ from geriatric population. Hence we hypothesise that the role of IJVCI using ultrasound to predict post-spinal hypotension can be extrapolated in geriatric patients undergoing lower limb surgeries. |