FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043036 [Registered on: 06/06/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   a study to determine if subclavian vein collapsibility corelates with inferior vena cava for assessment of intravascular volume 
Scientific Title of Study   Comparison of Subclavian vein and Inferior vena cava Collapsibility Index for Evaluation of Intravascular Volume Status in Intensive care unit by Ultrasonography-A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rangapriya 
Designation  post graduate 
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203
Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203
Kancheepuram
TAMIL NADU
603203
India 
Phone  9449058234  
Fax    
Email  Rangapriya.a@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajagopalan Venkatraman 
Designation  professor 
Affiliation  srm Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203
Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203
Kancheepuram
TAMIL NADU
603203
India 
Phone  09894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajagopalan Venkatraman 
Designation  professor 
Affiliation  srm Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203
Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203

TAMIL NADU
603203
India 
Phone  09894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology, Srm nagar, Potheri, kancheepuram District, Tamilnadu - 603203 
 
Primary Sponsor  
Name  SRM Medical College Hospital 
Address  Room no 1, B Block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU 
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 
Rangapriya A  SRM Medical College Hospital  Room no 1, B Block, Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur Kancheepuram TAMIL NADU Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 		 09449058234

Rangapriya.a@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL   NIL 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ● Patient aged above 18 years
● Patient undergoing major abdominal surgeries.
o Medical patients requiring inotropic support
• Other hypovolemic patients
 
 
ExclusionCriteria 
Details  ● Pregnancy
● Patient refusal
● Uncooperative patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the collapsibility index of Inferior vena cava and Subclavian vein for determining the intravascular volume.  2 to 3 hours after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the mean time to data acquisition between IVC-CI and SCV-CI approaches.  2-3 hours after surgery 
 
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)   13/06/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Inferior vena cava collapsibility index is considered as a standard method to know the volume status of a patient. where as certain situations where it cannot be measured such as patients with large abdominal dressing, obese patients etc will require an alternative method of assessing the volume status. hence we chose to see if subclavian vein corelates as it is more superficial and easy to access and less time consuming. therefore, patients admitted in the ICU and on inotropic supports , undergone major abdominal surgeries and other causes leading to hypovolemic status will be included in the study. collapsibility index of the subclavian vein and inferior vena cava will be compared by obtaining a minimum of 2-3 readings per patient. the time taken to record the values will also be noted. and compared for the efficacy of the collapsibility index of subclavian vein as an alternative for inferior vena cava. 
Close