Completed

TEE LVEDATransesophageal Echocardiology Measured Left Ventricular End Diastolic Area (LVEDA) As Guide for Fluid Therapy in Major Oncosurgeries

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What is being tested

LVEDA cm2 guided intraoperative fluid in TEE /Study Group

+ CVP guided intraoperative fluid in CVP / Control group

Procedure
Who is being recruted

From 18 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2019
See protocol details

Summary

Principal SponsorRajiv Gandhi Cancer Institute & Research Center, India
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 6, 2019

Actual date on which the first participant was enrolled.

Adult patients undergoing major oncosurgeries will be included in the study ,with Alpha Error(%) = 5 ,Power(%)= 80 ,required sample size per group is 29.Investigators will include 30 patients in each group. Patients will be randomly allotted to Central Venous Pressure CVP Group (Control Group) or Transesophageal Echocardiography TEE Group (Study Group) according to computer generated randomization. In the OR 5 lead Electrocardiogram ( ECG ), Oxygen saturation (SPO2 ), Noninvasive blood Pressure (NIBP) , End tidal carbon di oxide (ETCO2 )monitors will be attached .Under local anesthesia 16Gauge peripheral intravenous and Radial artery cannulation will be performed . Anesthesia will be induced with Fentanyl 1mcg/kg-1, Morphine 0.05mg/kg-1, Propofol titrated dosage 1-2 mg/kg-1 and neuromuscular blockade with Atracurium 0.5mg/kg-1.Trachea will be intubated with oral cuffed endotracheal tube of appropriate size. Anaesthesia will be maintained with O2 / Air mixture 40:60 % Intermittent Positive Pressure Ventilation with Sevoflurane , intermittent boluses of Fentanyl and Train of Four ratio guided Atracurium . Postintubation ultrasound guided internal jugular vein will be cannulated with B.Braun 7French 20cm, 16 G Triple lumen central venous catheter in both CVP and TEE Group patients . My Lab Five ESAOTE TEE 022 multiplane probe ,frequency 3 to7MHz (Providian Medical Equipment ,OH) will be placed in TEE Group patients.Intraoperative all patients will be given one-third starvation fluid in first hour of surgery , maintenance fluid 2ml/hour crystalloid . Target is to maintain CVP between 10 -16 cms of water (H20) in CVP Group , values will be recorded every 30 minutes if CVP decreases < 10 then 200 ml colloid bolus will be given and increase in CVP value noted . In the TEE Group TEE probe will be inserted in the oesophagus (40-45 cms) adjusted to obtain mid-papillary transgastric short axis view ,the desired view will be freezed at end-diastole and the left ventricular cavity will be traced including the papillary muscles to obtain left ventricular end diastolic area in cm2 , the average of three readings at particular interval will be noted . Every half hourly values will be measured and also if systolic blood pressure < 90 mm Hg . Fluid therapy will be given with the target to maintain LVEDA ≥ 10 cm2 (ranging between 10-18 cm2). For readings < 10 cm2 colloid bolus 200 ml will be given and increase in the LVEDA will be noted.For same readings Left Ventricular Outflow trac ( LVOT) view will be obtained to measure aortic diameter at the cusps and LVOT VTI , Stroke volume ( SV) will be calculated as LVOT area { Pi (LVOT diameter /2 } 2 × LVOT VTI and Cardiac Outpt will be calculated as SV x Heart Rate . Increase in stoke volume and cardiac output with colloid boluses will be noted.Urine output will be recorded every 30 minutes in all the patients.Titrated noradrenaline infusion (conc 0.08mg/ml ) will be started if Mean Arterial Pressure (MAP) < 70 mmHg with optimal fluid administration in CVP and TEE group .Serum lactate levels will be measured on completion of surgery and postoperative at 24 and 48 hours, neuromuscular blockade will be reversed and trachea extubated . In PACU both groups will receive CVP guided intravenous fluids, monitoring will include heart rate , Blood Pressure ,SPO2 , CVP , urine output. Note will be made of any patient requiring postoperative ventilator support, inotropic support,return of bowel sounds, serum lactate levels and serum creatinine levels at 24 and 48 hours and length of ICU stay.

Official TitleTransesophageal Echocardiology Measured Left Ventricular End Diastolic Area (LVEDA) As Guide for Fluid Therapy in Major Oncosurgeries
NCT03853031
Principal SponsorRajiv Gandhi Cancer Institute & Research Center, India
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Patients undergoing major abdominopelvic oncosurgeries .

5 exclusion criteria prevent from participating
oesophageal varices

carcinoma oesophagus

carcinoma stomach

coagulopathies

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients in TEE group will be given crystalloid fluids during surgery guided by LVEDA cm2 to be maintained between 10 -18 cm2 , if LVEDA \< 10 cm2 then 200ml colloid bolus will be given and increase in LVEDA noted.

Group II

Active Comparator
Patients in CVP group will be given crystalloid fluids during surgery guided by CVP values to be maintained between 10 -16 cms of water H2O ,if CVP value \< 10 cms H2O then 200 ml colloid bolus will be given and increase in CVP value noted.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Anita Kulkarni

Delhi, IndiaOpen Anita Kulkarni in Google Maps
CompletedOne Study Center