| 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. |
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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 |
|
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Primary Sponsor
|
| Name |
Internal fluid research grant |
| Address |
Christian Medical College, Vellore, Tamil Nadu 632004 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
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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
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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 |
|
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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
|
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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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