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CTRI Number  CTRI/2025/03/082209 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Left ventricular outflow tract velocity time integral versus inferior vena for predicting hypotension in abdominal hysterectomy patients  
Scientific Title of Study   Left ventricular outflow tract velocity time integral versus inferior vena cava collapsibility index for prediction of spinal anaesthesia induced hypotension during abdominal hysterectomy an 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  Shubham Vasantrao Londhe  
Designation  Junior Resident  
Affiliation  Lokmanya Tilak Municipal Medical college and General hospital sion Mumbai  
Address  4th floor Department of Anaesthesiology college building Lokmanya Tilak Municipal Medical college and General hospital sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8459361794  
Fax    
Email  shubhamlondhe333999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti S Rustagi  
Designation  Associate Professor Department of Anaesthesiology LTMMC sion mumbai  
Affiliation  3rd floor Department of Anaesthesiology sion hospital  
Address  3rd floor Department of Anaesthesiology college building sion hospital

Mumbai
MAHARASHTRA
400022
India 
Phone  9769215359  
Fax    
Email  drpreetirustagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shubham londhe 
Designation  Junior resident 
Affiliation  3rd floor Department of Anaesthesiology college building sion hospital  
Address  3rd floor Department of Anaesthesiology college building sion hospital

Mumbai
MAHARASHTRA
400022
India 
Phone  8459361794  
Fax    
Email  shubhamlondhe333999@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical college and General hospital sion mumbai,India 400022 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical college and General hospital sion mumbai  
Address  Lokmanya Tilak Municipal Medical college and General hospital sion mumbai 400022. Sion 
Type of Sponsor  Government 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 
Shubham Vasantrao Londhe   Lokmanya Tilak Municipal Medical college and General hospital sion Mumbai   4th floor Department of Anaesthesiology college building sion hospital Mumbai
Mumbai
MAHARASHTRA 
8459361794

shubhamlondhe333999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human research Lokmanya Tilak Municipal Medical college and General hospital Sion Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. All patients undergoing elective abdominal hysterectomy surgery with spinal anesthesia age 40- 70 years.
2. American Society of Anesthesiologists- Physical status (ASA-PS 1,2,3)
3. Patients willing to participate in our study  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To measure LOVT VTI and assess its specificity, sensitivity and predictive value for hypotension after spinal anaesthesia
 
2,4,6,8,10,12,14,16,18,20 min after induction of anaesthesia.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To measure LOVT VTI & assess its specificity, sensitivity & predictive value for hypotension after spinal anaesthesia
2.To measure & assess IVC collapsibility index ultrasonographically & assess its specificity, sensitivity & predictive value for hypotension after spinal anesthesia
3.To compare the predictive value of both these indices for hypotension prediction after spinal anesthesia

 
2,4,6,8,10,12,14,16,18,20 min after induction of anaesthesia  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/03/2025 
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 - NO
Brief Summary   Spinal anaesthesia is a safe and reliable method frequently used in various lower abdominal, orthopaedic, obstetric and gynaecological surgeries. It has advantages such as the rapid onset of action, cost-effectiveness and ease of administration. However, hypotension and bradycardia are common side effects of spinal anaesthesia that may lead to several adverse outcomes including coronary ischaemia and delirium. Hypotension following spinal anaesthesia results from the sympathetic blockade and decreased cardiac output (1). Patients with inadequate volume reserve before induction of anaesthesia, older age, known hypertensives, patients with diabetes mellitus are highly susceptible for post- spinal hypotension. Many methods such as preventive empirical volume loading or prophylactic vasopressors, have been used to lower the incidence of hypotension following spinal anaesthesia (2). However, intravenous volume preload carries the potential for volume overload, particularly in patients with cardiac disease (3). Furthermore, due to different definitions of hypotension and diverse patient populations, the effect of volume preload on prevention of hypotension is still controversial. (2)
While recognition and correction of latent hypovolemia are crucial for safe spinal anesthesia practice, assessment of the intravascular volume status is challenging for clinicians. Traditionally anaesthetists have assessed static hemodynamic modalities such as blood pressure, heart rate (HR) variability, central venous pressure for assessing volume status. 
Point of care ultrasound (POCUS) and focused cardiac ultrasound are now considered the 21st century stethoscopes with the unparalleled diagnostic modality as they provide real time, dynamic assessment of patient’s hemodynamic status.
Sonographic determination of inferior vena cava (IVC) diameter collapsibility index (IVCCI) has been extensively used for assessing volume status. But. IVCCI was found to have poor diagnostic accuracy for prediction of post-spinal anaesthesia hypotension (PSH) in spontaneously breathing patients predicting post-spinal hypotension in adult patients undergoing elective surgery. (4)
The change in dimensions of the IVC depends entirely on fluctuations in intrathoracic pressure therefore, in spontaneously breathing patients, the degree and the rate of the respiratory effort is an important and difficult-to-quantify variable. Thus, respiratory variations in the IVC diameter provide only weak to moderate diagnostic accuracy in predicting fluid responsiveness (5,6)
The left ventricular outflow tract (LVOT) is the origin of cardiac output. Velocity time integral (VTI) is the length of the hypothetical column of blood which passes through Doppler ultrasound. The left ventricular outflow tract velocity time integral (LVOT VTI) as assessed by transthoracic echocardiography (TTE), is being used in intensive care as a measure of stroke volume (SV) and to guide fluid therapy. (7) LVOT -VTI has been reported to have good diagnostic accuracy (77.4%) for prediction of hypotension after general anaesthesia. (8,9)
Women undergoing abdominal hysterectomy are likely to develop post spinal hypotension (PSH) often due to advanced age, starvation , bowel preparation before surgery and sometimes large uterus size due to large fibroids. Accurate prediction of spinal anesthesia-induced hypotension could enhance clinical decision-making, alter therapeutic management, and lead to appropriate early interventions. Hence this prospective observational study is designed to assess the diagnostic accuracy of LVOT -VTI for prediction PSH in patients undergoing elective abdominal hysterectomy and to compare it with IVC-CI. 

 
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