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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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