| CTRI Number |
CTRI/2021/07/035060 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
IVC COLLAPSIBILTY INDEX USE FOR IDENTIFYING FALL IN BLOOD PRESSURE AFTER SPINAL ANAESTHESIA IN ORTHOPEDIC PATIENTS UNDERGOING ELECTIVE SURGERIES. |
|
Scientific Title of Study
|
IVC COLLAPSIBILTY INDEX AS A PREDICTOR FOR POST SPINAL HYPOTENSION IN ORTHPEDIC PATIENTS UNDERGOING ELECTIVE SURGERIES- A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sitara Raghavan Nandyal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba hospital
Manipal
Udupi
Manipal University,Madhavnagar
Udupi
KARNATAKA
576104
India |
| Phone |
09030816425 |
| Fax |
|
| Email |
sitara1311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology Kasturba Hospital
Manipal- 567104
Udupi
KARNATAKA
576104
India |
| Phone |
09008415858 |
| Fax |
|
| Email |
arun.hd@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology Kasturba Hospital
Manipal- 567104
KARNATAKA
576104
India |
| Phone |
09008415858 |
| Fax |
|
| Email |
arun.hd@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal Madhavanagar - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sitara Raghavan Nandyal |
| Address |
1216,New International Hostel -A block, Madhavanagar, Manipal, 576104 |
| 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 Sitara Raghavan Nandyal |
Kasturba Hospital, Manipal |
Main OT complex, Department of Anaesthesiology, Udupi, Karnataka
Udupi
KARNATAKA |
9030816425
sitara1311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y849||Medical procedure, unspecified asthe cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Orthopaedic patients of either gender, aged 18-60 years posted for elective surgeries under spinal anaesthesia in supine position
-Consented for participating in the study ASA physical status I or II
|
|
| ExclusionCriteria |
| Details |
Unwilling to participate in the study
Pre-existing cardiovascular, renal, respiratory illnesses Emergency surgeries
Patients who have received preloading of IV fluids Patients with difficulty in communication
Anticipated severe intraoperative blood loss needing blood transfusion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the correlation of pre-spinal IVC collapsibility index measurement to
predict post spinal hypotension.
|
2.5 mins post spinal anaesthesia,
5 mins post spinal anaesthesia,
7.5 mins post spinal anaesthesia,
10 mins post spinal anaesthesia,
12.5 mins post spinal anaesthesia,
15 mins post spinal anaesthesia,
17.5 mins post spinal anaesthesia,
20 mins post spinal anaesthesia,
22.5 mins post spinal anaesthesia,
25 mins post spinal anaesthesia,
27.5 mins post spinal anaesthesia,
30 mins post spinal anaesthesia.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: IVC collapsibilty index as a predictor for post spinal hypotension in orthopedic patients undergoing elective surgeries- A prospective observational study Type of Study: A prospective single center, observational study Aim: To assess the correlation of pre spinal IVC collapsibility index measurement to predict the post spinal hypotension |