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CTRI Number  CTRI/2021/10/037304 [Registered on: 13/10/2021] Trial Registered Prospectively
Last Modified On: 10/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of inferior vena cava collapsibility index and internal jugular vein collapsibility index for prediction of hypotension after spinal anaesthesia. 
Scientific Title of Study   INFERIOR VENA CAVA COLLAPSIBILITY INDEX VS INTERNAL JUGULAR VEIN COLLAPSIBILITY INDEX FOR PREDICTION OF POST SPINAL HYPOTENSION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suneet Kant Kathuria 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  Room no 4, Deptt of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana.
Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  9814007622  
Fax    
Email  suneetkathuria@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suneet Kant Kathuria 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  Room no 4, Deptt of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana.
Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  9814007622  
Fax    
Email  suneetkathuria@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sukhkamal Singh 
Designation  Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  Intern boys Hostel, Room no 178, Dayanand Medical College and Hospital, Ludhiana.
Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  7009810949  
Fax    
Email  singhsukhkamal5@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Ludhiana 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital Ludhiana 
Address  Civil Lines, Tagore Nagar, Ludhiana, Punjab 
Type of Sponsor  Private medical college 
 
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 Suneet Kant Kathuria  Dayanand Medical College and Hospital  Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 		 9814007622

suneetkathuria@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dayanand Medical College and Hospital, Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INFERIOR VENA CAVA COLLAPSIBILITY INDEX  IVC collapsibility index will be measured using ultrasound (M-Mode) 
Intervention  INTERNAL JUGULAR VEIN COLLAPSIBILITY INDEX  IJV collapsibility index at 0 degree and 30 degree will be measured using ultrasound (M-Mode) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • Patients > 18 years of age.
• Patients undergoing surgery under spinal anaesthesia.
• ASA I, II, III patients. 
 
ExclusionCriteria 
Details  • Consent refusal by the patient for study
• Infection at the site of spinal injection
• Patients with severe hypovolemia or haemorrhagic shock
• Pre-existing severe neurological, cardiac, renal or liver disease
• Thrombocytopenia and Coagulopathies
• Patient currently taking anti-coagulant/anti-platelet therapy
• Spine injury
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will compare the efficacy of inferior vena cava and internal jugular vein collapsibility index in prediction of hypotension in a patient undergoing spinal anaesthesia.

 		 The inferior vena cava and internal jugular vein collapsibility index will be assessed after shifting the patient to OT table and baseline values of HR, SpO2, systolic, diastolic and mean blood pressure will be recorded. After giving spinal HR and BP will be measured every 1 minute for first ten minutes and every 2 minutes thereafter for next 20 minutes. The outcome will be assessed after every 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare IJV collapsibility index at 0áµ’ and 30áµ’ head elevated position in prediction of post spinal hypotension.  The internal jugular vein collapsibility index will be assessed in supine position and at 30áµ’ head up position before giving spinal anaesthesia and baseline values of HR, SpO2, systolic, diastolic and mean blood pressure will be recorded. After giving spinal HR and BP will be measured every 1 minute for first ten minutes and every 2 minutes thereafter for next 20 minutes. The outcome will be assessed every 8 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/10/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Inferior vena cava and internal jugular vein collapsibility index are increasingly used as non invasive tools to predict hypovolemia in emergency and critical care settings. Hypotension is a common intraoperative complication after spinal anaesthesia, as a result of sympathetic blockade. Successful prediction of post spinal hypotension can help in adoption of appropriate preventive and treatment measures to minimise peri operative morbidity. Our aim is to compare inferior vena cava and internal jugular vein collapsibility index to predict hypotension after spinal anaesthesia. A prospective observational study will be conducted on 50 adult patients of ASA I, II and III undergoing surgery under spinal anaesthesia. After giving spinal anaesthesia using a standard protocol, monitoring of heart rate, systolic, diastolic and mean blood pressure will be done upto 30 minutes to compare incidence and severity of hypotension.  The inferior vena cava collapsibility index and internal jugular vein collapsibility index will be compared as a tool for prediction of post spinal hypotension. 
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