CTRI Number |
CTRI/2017/06/008866 [Registered on: 19/06/2017] Trial Registered Retrospectively |
Last Modified On: |
15/06/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Ultrasound guided assessment of inferior vena cava compressibilty to assess incidence of hypotension after spinal anaesthesia |
Scientific Title of Study
|
Inferior Vena Cava compressibility index as a predictor of hypotension during Spinal Anaesthesia. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nikhil Kothari |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Jodhpur |
Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
Phone |
8003996948 |
Fax |
|
Email |
drnikhilkothari@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nikhil Kothari |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Jodhpur |
Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
Phone |
8003996948 |
Fax |
|
Email |
drnikhilkothari@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nikhil Kothari |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences Jodhpur |
Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
Phone |
8003996948 |
Fax |
|
Email |
drnikhilkothari@gmail.com |
|
Source of Monetary or Material Support
|
Intramural funding by Research Cell, All India Institute of Medical Sciences, Jodhpur. |
|
Primary Sponsor
|
Name |
Research Cell |
Address |
All India Institute of Medical Sciences, Jodhpur. |
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 Nikhil Kothari |
All India Institute of Medical Sciences, Jodhpur. |
Operation Theatre,
3rd Floor, OPD Building. Jodhpur RAJASTHAN |
8003996948
drnikhilkothari@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS JODHPUR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients above 18 yrs of age posted for surgery under spinal anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
USG assesment. |
USG assesment of Inferior Vena Cava at the level of hepatic vein using low frequency abdominal/cardiac probe prior to spinal anaesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
1) Age 18 yrs and above.
2) Patients presenting for below umbilical or lower limb surgeries under spinal anaesthesia.
|
|
ExclusionCriteria |
Details |
1) Patient refusal.
2) Coagulation disorders (international normalised ratio or activated partial thromboplastin time ratio > 2.5, platelet count < 106 / µL).
3) Allergy to local anaesthetic.
4) Infection at the site of spinal anaesthesia.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of hypotension after spinal anaesthesia. |
30 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Requirement of vasopressors for hypotension after spinal anaesthesia, in both groups.
2) Volume of fluid bolus required for hypotension after spinal anaesthesia, in both groups.
|
till end of surgery. |
|
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)
|
02/02/2016 |
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) |
Open to Recruitment |
Publication Details
|
Data Collection |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Brief Summary Type of study: Prospective Observational Study. Inclusion criteria: 1) Age 18 yrs and above. 2) Patients presenting for below umbilical or lower limb surgeries under spinal anaesthesia. Exclusion criteria: 1) Patient refusal. 2) Coagulation disorders (international normalised ratio or activated partial thromboplastin time ratio > 2.5, platelet count < 106 / µL). 3) Allergy to local anaesthetic. 4) Infection at the site of spinal anaesthesia. Methodology: After approval from Institute’s Ethics committee, a prospective cohort study will be planned on patients scheduled to undergo elective surgery under spinal anaesthesia. The patients included will be of American Society of Anaesthesiologists (ASA) physical status grade I or II and aged between 18 to 80 years. It will be observed that written informed consent is taken from every patient, prior to the surgery. After collection of data the patient’s cohort will be created depending upon the IVC compressibility: Group A: IVC compressibility < 50%. Group B: IVC compressibility > 50%. It will be observed that the pre anaesthetic check-up (PAC), routine blood and other investigations of need are properly carried out. Standard monitoring of electrocardiography (ECG), pulse oximetry, blood pressure, respiratory rate, axillary skin temperature and end tidal carbon dioxide are attached, along with it, an intravenous (i.v.) infusion of Lactated Ringer’s solution is started prior to shifting the patient in operation theatre. An independent observer will note the IVC diameter using high frequency 2D Echocardiography (2D ECHO) probe in sub xiphoid region. IVC is visualised as hypoechoeic structure, whose diameter varies with respiration. IVC diameter will be observed under M-mode, at 1 cm caudal to opening of hepatic vein, as visualised under 2D ECHO. IVC is normally 1.5 to 2.5 cm in diameter when measured 1 cm caudal to opening of hepatic vein. Diameter of IVC less than 1.5 cm suggests volume depletion and IVC diameter greater than 2.5 cm suggests volume overload. In spontaneously breathing patients, IVC collapsibility index will be noted under M-mode of 2D ECHO using following equation: IVC collapsibility index = [(Maximum IVC diameter) - (Minimum IVC diameter)] [Mean IVC diameter] Once the IVC collapsibility index is noted, as done routinely the patient will be shifted to operation room (O.R). The observer who has noted the IVC collapsibility index will not accompany the patient in the O.R. Inside the O.R. an independent observer who is a part of the study will note the vitals (heart rate and blood pressure) prior to giving spinal anaesthesia and after giving spinal anaesthesia, the readings will be noted at an interval of 5 minutes. Inside O.R, the observer will note the incidence of hypotension, amount of fluid given as bolus and the amount of vasopressor (phenylephrine) required. The patients in both the cohort groups will be similar in respect to their age, ASA physical status and type of surgical procedure done. |