| CTRI Number |
CTRI/2024/02/062673 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Change in the size of large blood vessel during breathing in and breathing out as a predictor of low blood pressure after spinal anaesthesia in patients undergoing surgery for hip fracture |
|
Scientific Title of Study
|
Evaluation of inferior vena cava collapsibility index as a predictor for hypotension after spinal anaesthesia in patients undergoing surgery for hip fractures: 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 Prerna Das |
| Designation |
DNB Postgraduate trainee |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Dept of Anaesthesia and Pain Medicine, 2nd Floor OT Complex, Medica Superspecilaty Hospital, Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8017517100 |
| Fax |
|
| Email |
prerna6494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaya Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Dept of Anaesthesia and Pain Medicine, 2ND Floor OT Complex, Medica Superspecilaty Hospital, Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8017517100 |
| Fax |
|
| Email |
jayachoudhry11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaya Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Medica Superspecialty Hospital |
| Address |
Dept of Anaesthesia and Pain Medicine, 2ND Floor OT Complex, Medica Superspecilaty Hospital, Kolkata
Kolkata
WEST BENGAL
700099
India |
| Phone |
8017517100 |
| Fax |
|
| Email |
jayachoudhry11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medica Superspecialty Hospital |
|
|
Primary Sponsor
|
| Name |
Medica Superspecialty Hospital |
| Address |
127, Mukundapur, EM Byepass, Kolkata 700099 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Jaya Choudhary |
Medica Superspecialty Hospital |
Dept of Anaesthesia, 2nd Floor OT Complex, 127, Mukundapur, EM Byepass, Kolkata
Kolkata
WEST BENGAL |
8017517100
jayachoudhry11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CREC Medica Superspecialty Hospital, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ultrasound guided scanning of inferior vena cava and calculation of IVC collapsibility index |
In the procedure room ultrasound guided scanning of IVC will be carried out for each patient by an experienced anaesthesiologist. With patient in supine position, IVC measurements will be performed using curvilinear probe (2-5 Hz) with a B mode scan. The transducer will be placed in the subxiphoid region in a longitudinal orientation. IVC will be identified by Doppler waveform for each patient. IVC measurements will be made just distal to IVC- Hepatic vein junction. The maximum IVC diameter (IVCDmax) and minimum IVC diameter (IVCDmin) at the end of expiration and inspiration respectively over the same respiratory cycle will be recorded. The IVC collapsibility index will be calculated using the formula: (IVCDmax- IVCDmin)/ IVCDmax X 100. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists (ASA) physical status I – III.
2.Scheduled to undergo hip surgery under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Absolute or relative contraindication to spinal anaesthesia
a)Coagulopathy
b)Local site infection
c)Symptoms or signs of raised intracranial pressure
d)Known allergy to local anaesthetics
e)Severe Aortic stenosis or mitral stenosis (Fixed cardiac output state)
f)Shock
g)Sepsis
3.Failure to perform spinal anaesthesia or inadequate block requiring conversion to general anaesthesia
4.BMI > 30kg/m2
5.Difficulty in identifying intrahepatic IVC
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Episodes of hypotension |
Every 3 minutes for the first 15min, at 30 min and every 30 min till the end of the procedure, once in the recovery room and once at 24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Episodes of bradycardia, nausea and vomiting, allergic reaction, dizziness, chest discomfort or shivering. |
Every 3 minutes for the first 15min, at 30 min and every 30 min till the end of the procedure, once in the recovery room and once at 24 hrs after surgery |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/03/2024 |
| 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 causes a significant mortality and morbidity in patients undergoing hip fracture surgery under spinal anaesthesia. 108 patients will be enrolled meeting the inclusion criteria will be studied. IVC collapsibility index will be calculated preoperatively for each patient and standard spinal anaesthesia will be administered. Blood pressure will be recorded at regular intervals and episodes of hypotension will be recorded. At the end of the study, correlation between IVC collapsibility index and episodes of hypotension if any will be identified. |