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CTRI Number  CTRI/2025/04/085925 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To evaluate the performance of the heart and response to iv fluids and blood in patients undergoing abdominal operations, using a technique that utilises artery cannulation and another, that requires  ultrasonography of the heart.  
Scientific Title of Study   Correlation between Pulse Pressure Variation (PPV) and Aortic Velocity Time Integral (VTI) variability as measures of fluid responsiveness in patients undergoing major abdominal surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Merin David  
Designation  Pg Resident 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anaesthesia, Christian Medical College, Vellore
Room no, 916, Ladies Interns quarters, Christian Medical College, Vellore, 632004
Vellore
TAMIL NADU
632004
India 
Phone  7837916130  
Fax    
Email  smdur_friend@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Rahul Pillai 
Designation  Professor 
Affiliation  Christian Medical College, Vellore  
Address  Department of anaesthesia, Christian medical College, Vellore
Department of anaesthesia, Christian medical College, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9894460758  
Fax    
Email  cmcrahulpillai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sneha Merin David  
Designation  Pg resident 
Affiliation  Christian Medical College, Vellore  
Address  Department of Anaesthesia, Christian Medical College, Vellore
Room no 916, Ladies Interns quarters, CMC vellore 632004
Vellore
TAMIL NADU
632004
India 
Phone  7837916130  
Fax    
Email  smdur_friend@yahoo.in  
 
Source of Monetary or Material Support  
Internal Fluid Grant, Christian Medical college, vellore, Tamil Nadu, 632004 
 
Primary Sponsor  
Name  Internal fluid research grant 
Address  Christian Medical College, Vellore, Tamil Nadu 632004 
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 
Sneha Merin David  Christian medical college Vellore  Department of general surgery, unit 2, 3, 4 and Department of hepato- pancreato biliary surgery,
Vellore
TAMIL NADU 
07837916130

smdur_friend@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board (irb) office of research christian medical college Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients scheduled for major elective abdominal surgery requiring invasive monitoring. 
 
ExclusionCriteria 
Details  • Age under 18 years
• BMI under 18 kg per meter square
• Severe heart valve disease
• Known intra-and/or extracardiac shunt
• Pulmonary hypertension
• Pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
A correlation coefficient between 0.5 -1.0  Baseline, every 1 hourly and whenever there’s a significant blood loss 
 
Secondary Outcome  
Outcome  TimePoints 
Change in cardiac output and stroke volume with fluid bolus, at least 10-15%  Baseline, every 1 hourly and whenever there’s a significant blood loss 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   29/04/2025 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

A "major abdominal surgery" is an intraperitoneal procedure that involves either luminal resection or the excision of a solid organ connected to the gastrointestinal tract and does not primarily involve the thorax. Such surgeries may be associated with significant fluid loss as well as significant fluid shifts. These fluid changes may occur preoperatively as well as intraoperatively. Preoperative factors include bowel preparation (elective surgery) and vomiting, gastric decompression and/or drainage, sequestration of fluid, diarrhea, and bleeding (urgent surgery). Intraoperative, factors include insensible losses (traditionally assumed to amount up to 4–8 ml/kg/h for major abdominal surgery), intraoperative bleeding, gastric drainage, and drainage of ascites. These, if not appropriately monitored and treated, may adversely impact surgical outcomes and increase morbidity and mortality. Hemodynamic monitoring in these patients involves the use of various methods to directly measure cardiovascular parameters such as cardiac output, systemic vascular resistance, and central venous pressure. Commonly used techniques include pulmonary artery catheterization, echocardiography, and arterial waveform analysis. Monitoring cardiac output (CO) as an indicator of macrocirculation remains a cornerstone in guiding therapeutic interventions for critically ill patients and during major surgeries. Thermodilution based CO measurement via pulmonary artery catheter (with a swan-Ganz probe) is considered the gold-standard technique, but its invasiveness limits its routine clinical use. Among all the indices of fluid responsiveness, pulse pressure variation (PPV) using arterial cannulation has been one of the most used in clinical practice. PPV reflects the respiratory changes in stroke volume and, thus, should help assess fluid responsiveness. This is assuming that arterial compliance does not change over the respiratory cycle, a hypothesis that has been confirmed experimentally. Today, most hemodynamic monitors allow automatic calculation of PPV with continuous display of its value in real time. Currently, the main focus of research and development is towards less invasive monitors with inherently lower risks of use. Availability of portable ultrasound machines has made noninvasive measurement of hemodynamic parameters, such as aortic blood flow (ABF) or Aortic velocity time integral (VTI), possible. The aortic velocity time integral (VTI) is an echocardiographic tool used to estimate cardiac output (CO) by multiplying it with the aortic valve (AV) area and heart rate (HR). The aortic VTI itself can serve as a left-ventricular (LV) output parameter. n this study we aim to compare PPV with Aortic VTI as measured by Transthoracic Echo in patients coming for major abdominal surgeries.


 
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