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CTRI Number  CTRI/2024/10/075158 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Single Arm Study 
Public Title of Study   Using ultrasound to predict predict low blood pressure after giving anaesthesia- a bedside test  
Scientific Title of Study   Preanaesthesia ultrsound monitoring of subclavian vein diameter changes induced due to spontaneous respiration along with modified passive leg raise to predict the occurrence of hypotension after general anaesthesia in patients posted for elective surgeries- Prospective observational 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  V Vinay Krishna 
Designation  PG Resident 
Affiliation  Chettinad Academy of Research and education 
Address  Department of Anaesthesiology Chettinad academy of Research and education Chettinad health city Rajiv Gandhi salai Kelambakkam Kancheepuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  9962607991  
Fax    
Email  vinaykrishnav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Merlin Shalini Ruth 
Designation  Professor 
Affiliation  Chettinad Academy of Research and education 
Address  Department of Anaesthesiology Chettinad academy of Research and education Chettinad health city Rajiv Gandhi salai Kelambakkam Kancheepuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  9790983957  
Fax    
Email  merlin5shalini@gmail.com  
 
Details of Contact Person
Public Query  
Name  V Vinay Krishna 
Designation  PG Resident 
Affiliation  Chettinad Academy of Research and education 
Address  Department of Anaesthesiology Chettinad academy of Research and education Chettinad health city Rajiv Gandhi salai Kelambakkam Kancheepuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  09962607991  
Fax    
Email  vinaykrishnav@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu, India-603103 
 
Primary Sponsor  
Name  Merlin Shalini Ruth 
Address  Dr Merlin Shalini Ruth Professor Department of Anaesthesiology Chettinad academy of Research and education Chettinad health city Rajiv Gandhi salai Kelambakkam Kancheepuram district 
Type of Sponsor  Other [SELF] 
 
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 
V Vinay Krishna  Chettinad academy of research and education  Department of Anaesthesiology D block 1st floor Chettinad academy of Research and education Chettinad health city Rajiv Gandhi salai Kelambakkam Kancheepuram district
Kancheepuram
TAMIL NADU 		 9962607991

vinaykrishnav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee- Chettinad  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 18-70 years ​
Elective surgeries​
ASA : I, II ​
General Anaesthesia ​ 
 
ExclusionCriteria 
Details  Patient refusal​

Age : < 18 years​

Emergency surgeries ​

Systolic Blood Pressure > 180 mmHg and < 90 mmHg on day of surgery​

Uncontrolled hypertension ​

Patient with lower limb fracture/dislocation​
Patients with a history of heart failure, moderate or severe valvular heart disease, aortic disease, peripheral arterial disease, left ventricular ejection fraction less than 40% or ASA III or worse will be excluded.​ 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine correlation between pre anaesthesia ultrasound monitoring of subclavian vein diameter changes induced due to spontaneous respiration along with modified passive leg raise to predict the occurrence of hypotension after general anaesthesia in patients posted for elective surgeries   Baseline 10 min post induction of general anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To determine if any correlation exists between sex & changes in collapsibility index​  Baseline 10 min post induction of general anaesthesia 
 
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)   01/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Induction of general anesthesia is often associated with hypotension and is a common scenario faced by anesthesiologists. The degree of hypotension can depend on age, comorbidities and anesthetic drugs used during general anesthesia. (1)​
 Intraoperative hypotension can have detrimental effects and cause adverse effects such as myocardial infarction, stroke, and acute kidney injury leading to extended hospital stay. (2)​
Therefore, preventing early intraoperative hypotension and maintaining hemodynamic stability can improve patient outcomes. (3)
Patient’s preinduction volume status can have an effect on postinduction hypotension, considering long periods of fasting for elective surgeries. (4)​
Ultrasonography of Inferior Vena Cava diameter (DIVC) and Collapsibility Index of Inferior Vena Cava diameter (DIVC-CI) has been reported to be a useful tool for predicting post-GA hypotension.​
Ultrasound assessment of Inferior vena cava diameter has a few constrains like requirement of curvilinear probe and might have difficulties in visualizing it.​
The subclavian vein (SCV) is located adjacent to the pleura and upstream of the superior vena cava and can be easily visualized in most patients using a linear probe.​
USG Subclavian vein collapsibility index (DSCV-CI) has been shown to be effective in assessing intravascular volume status and intravascular volume measurements during spontaneous breathing as a surrogate partner for DIVC-CI (5).​
Pre-GA-induction ultrasonography of the internal jugular vein area (IJV-A) in the Trendelenburg position was reported to be an independent predictor of hypotension during GA induction and showed venous changes similar to those found in the PLR position (8)​
DSCV-CI was able to predict post GA hypotension in deep inspiration. (6)(7)​

 
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