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CTRI Number  CTRI/2024/09/074083 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 18/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Clinical Trial to determine if changes in Subclavian Vein diameter due to passive leg raising can predict intraoperative hypotension. 
Scientific Title of Study   Accuracy of Pre-Induction changes in Subclavian Vein Diameter and Collapsibility Index due to passive leg raising to predict the occurrence of Post-Induction hypotension in patients undergoing General Anaesthesia: A Cross-Sectional 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 Shadab Badar 
Designation  Junior Resident 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  1409, Mahdibagh Colony, Dr Ambedkar Marg P.O

Nagpur
MAHARASHTRA
440017
India 
Phone  8605772137  
Fax    
Email  shadab.badar1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Bhure 
Designation  Professor and Head, Department of Anaesthesiology 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.


MAHARASHTRA
440019
India 
Phone  9822563121  
Fax    
Email  anjali_bhure@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Shadab Badar 
Designation  Junior Resident Anaesthesiology 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.

Nagpur
MAHARASHTRA
440017
India 
Phone  8605772137  
Fax    
Email  shadab.badar1996@gmail.com  
 
Source of Monetary or Material Support  
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India. 440017 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur. 440019 
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 Shadab Badar  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur 440019
Nagpur
MAHARASHTRA 		 8605772137

shadab.badar1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur.  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Undergoing General Anaesthesia.
Patients satisfying American Society of Anaesthesiologists Class I, II and III. 
 
ExclusionCriteria 
Details  Patients undergoing emergency Surgery.
Patients with Peripheral Vascular Disease.
Patients with Cardiovascular Disease.
Patients with Pulmonary Disease.
Patients with Liver or Kidney Complications.
Patients with Circulatory Instability.
Patients unwilling to participate in study.
Patients with unclear ultrasound images. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the accuracy of Pre-induction changes in subclavian vein diameter and collapsibility index due to passive leg raising in predicting post-induction hypotension in patients undergoing General Anaesthesia.   Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Receiver operative Characteristic (ROC) Curve 
 
Secondary Outcome  
Outcome  TimePoints 
To find the accuracy of Pre-induction changes in subclavian vein diameter and collapsibility index due to passive leg raising in predicting post-induction hypotension in patients undergoing General Anaesthesia.   Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Receiver operative Characteristic (ROC) Curve 
 
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)   01/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 is a common side effect of general anaesthesia and might lead to inadequate organ perfusion. It may also play a role in the development of postoperative ischemic stroke.
Increasing degree of hypotension is strongly associated with myocardial injury, mortality, and renal injury in postoperative critical care patients.
Intraoperative Hypotension (IOH) during noncardiac surgery is common and associated with increased 30-day major adverse cardiac or cerebrovascular events.
IOH should be defined using the absolute values stated in the Perioperative Quality Initiative (POQI) statement i.e., MAP < 60–70 mmHg or MAP < 20% of baseline.
Passive Leg Raising(PLR) has been shown to transfer up to 300 ml of blood from the peripheral compartment to the Central Compartment.
A majority of the incidence of IOH occurs before incision. IOH if predicted preoperatively can be better managed and post operative complications can be
prevented.
There are various methods which can be a reliable predictor of intraoperative hypotension which include: The Hypotension Prediction Index(HPI), Inferior Vena Cava Collapsibility Index (IVC CI) and Internal Jugular Vein (IJV). The HPI does not take into account the administration of different anaesthetic drugs. The association
of maximum pupil size to hypotension is confounded by the age of the patient. It is difficult to measure the IVC in obesity, bowel gas, or complex abdominal wounds.IJV has low diagnostic Accuracy.
Prediction of IOH using ultrasound guided parameters which are non invasive can help reduce postoperative morbidity due to hypotension.
It takes less time for measuring subclavian vein diameter changes compared to inferior vena cava. Also, To the best of our knowledge, very few studies have been conducted to predict IOH using Subclavian Vein Diameter Changes.
Therefore we have planned this study with the aim to know whether there is a Correlation of Pre op changes in Subclavian Vein Diameter and Collapsibility Index due to passive leg raising with Post induction hypotension.
 
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