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CTRI Number  CTRI/2024/11/076669 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Combined Subclavian vein and internal jugular vein collapsibility index as a predictor of hypotension after induction of General anaesthesia in Hypertensive patients: A prospective observational study.  
Scientific Title of Study   Subclavian vein collapsibility combined with internal jugular vein collapsibility index as a predictor of hypotension after induction of general anaesthesia in hypertensive patients 
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 Urvasie Salam 
Designation  Academic JR 
Affiliation  All India Institute of Medical Sciences , Gorakhpur 
Address  Department of Anaesthesiology, AIIMS Gorakhpur
IPD building 1st floor, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  07085523145  
Fax    
Email  urvasiesalam96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijeta Bajpai 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences , Gorakhpur 
Address  Department of Anaesthesiology, AIIMS Gorakhpur
IPD building 2nd floor, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Urvasie Salam 
Designation  Academic JR 
Affiliation  All India Institute of Medical Sciences , Gorakhpur 
Address  Department of Anaesthesiology, AIIMS Gorakhpur
IPD building 1st floor, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7085523145  
Fax    
Email  urvasiesalam96@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Gorakhpur, Uttar Pradesh, India, 273008 
 
Primary Sponsor  
Name  AIIMS Gorakhpur 
Address  Department of Anaesthesiology, AIIMS Gorakhpur, Uttar Pradesh, India 273008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Urvasie Salam  All India Institute of Medical Sciences Gorakhpur  Department of Anaesthesiology, AIIMS Gorakhpur, Uttar Pradesh, India, 273008
Gorakhpur
UTTAR PRADESH 		 7085523145

urvasiesalam96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute Of Medical Sciences, Gorakhpur, Uttar Pradesh, India 273008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  USG evaluation of Subclavian vein(SCV)and Internal Jugular Vein(IJV)  In pre operative room- In Supine position, USG evaluation of SCV and IJV (spontaneously breathing) will be performed. High frequency linear probe (4–15 MHz , My Lab Omega Esaote, Florence, Italy) will be used to Measure right SCV and IJV dimension. For SCV Probe placement will be beneath the proximal part of the middle of the clavicle and will be scanned. For IJV Probe placement will be Perpendicular to the skin in the transverse plane on the neck at the level of the cricoid cartilage. Patient will be instructed to perform Deep intentional inhalation followed by Gradual and relaxed exhaling process.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60 years of either gender
ASA class II
History of controlled HTN with or without medications for more than 6months
BMI less than 35kg/m2
undergoing elective non cardiac surgery 
 
ExclusionCriteria 
Details  Patient refusal
Congenital or valvular heart disease or implanted pacemakers or currents ACEIs or ARBs medications.
History of CVA or peripheral vascular disease or chronic renal failure or DM or morbid obesity
Lateral or prone positions procedure
Emergency surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the accuracy of combined subclavian vein collapsibility index and internal jugular vein collapsibility index in predicting post induction hypotension after induction of general anesthesia in hypertensive patients.  1min 2min 3min 4min 5min 6min 7min 8min 9min 10min 11min 12min 13min 14min 15min 
 
Secondary Outcome  
Outcome  TimePoints 
To know the incidence of hypertension varying in particular age group, sex or antihypertensive drugs used  At baseline 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   23/11/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study

  2. What additional supporting information will be shared?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study
  3. Who will be able to view these files?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study

  4. For what types of analyses will this data be available?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study

  5. By what mechanism will data be made available?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study

  6. For how long will this data be available start date provided 28-09-2026 and end date provided 28-09-2031?
    Response (Others) -  Individual de identified participant data will be shared in supplementary file of published manuscript Data of outcome will be shared as a part of manuscript in peer reviewed journal after completion of the study

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a single arm, prospective, observational study to determine the feasibility of pre operative subclavian vein collapsibility index combined with internal jugular vein collapsibility index as a predictor of hypotension after induction of General Anesthesia in 160 hypertensive patients admitted at AIIMS Gorakhpur for elective non cardiac surgeries. The primary outcome measures will be to assess the accuracy of combined SCV CI and IJV CI in predicting post induction hypotension after induction of GA in hypertensive patients. Secondary measures are to know the incidence of hypotension varying in particular age group, duration of hypertension, gender or antihypertensive drugs used. 
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