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CTRI Number  CTRI/2022/05/042808 [Registered on: 25/05/2022] Trial Registered Prospectively
Last Modified On: 18/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Assessment of sensitivity of Trans-Esophageal Echocardiography for the measurement of cardiac output as compared to that obtained by thermodilution method by Pulmonary Artery Catheter in patients undergoing off-pump coronary artery bypass surgery 
Scientific Title of Study   Cardiac output measurement using Trans-esophageal echocardiography versus Thermodilution in patients undergoing off-pump CABG 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SUMAN KESHAV 
Designation  Senior resident, Cardiac Anaesthesia  
Affiliation  GIPMER 
Address  Department of Anaesthesiology, 6th floor, Academic Block G B Pant Hospital, New Delhi

New Delhi
DELHI
110002
India 
Phone  9480664980  
Fax    
Email  drsumankeshav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishnu Datt 
Designation  Director-Professor and Head of department of Cardiac Anaesthesiology  
Affiliation  GIPMER 
Address  Department of Anaesthesiology, 6th Floor, Academic block G B Pant Hospital New Delhi

New Delhi
DELHI
110002
India 
Phone  9718599406  
Fax    
Email  dattvishnu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr SUMAN KESHAV 
Designation  Senior resident, Cardiac Anaesthesia  
Affiliation  GIPMER 
Address  Department of Anaesthesiology, 6th floor, Academic block, G B Pant hospital, New Delhi

New Delhi
DELHI
110002
India 
Phone  9480664980  
Fax    
Email  drsumankeshav@gmail.com  
 
Source of Monetary or Material Support  
G B Pant Hospital, GIPMER, New Delhi 
 
Primary Sponsor  
Name  G B Pant hospital GIPMER New Delhi 
Address  Department of Anaesthesiology, 6th floor, Academic block, G B Pant hospital, GIPMER New Delhi 110002 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Suman Keshav   Cardio-thoracic and vascular surgery operation theatre, G B Pant hospital   2ND and 5TH Floor, B Block, G B Pant hospital, New Delhi
New Delhi
DELHI 
9480664980

drsumankeshav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients undergoing off pump CABG with LVEF less than 50%. 
 
ExclusionCriteria 
Details  1.Patients with mitral/aortic valve insufficiency or other significant valve abnormalities
2.Patients in non-sinus rhythm
3.Patients requiring inotropic support/IABP/haemodynamically unstable pre-operatively
4.Patients with right ventricular assist device
5.Patients with esophageal diseases
6.Patients requiring conversion from off pump CABG to on pump CABG
7.Patients with ventricular septal defects (VSD) and right ventricle outflow tract (RVOT) / LVOT obstruction.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Cardiac output by thermodilution method
2.Cardiac output by trans-esophageal echocardiography at aortic valve level
 
T1: Clinical steady state 15minutes after induction of anaesthesia
T2: After sternal closure 
 
Secondary Outcome  
Outcome  TimePoints 
1.Hemodynamic monitoring including heart rate, systolic, diastolic and mean arterial pressures and pulmonary artery pressure.  Every 60minutes throughout the operative period 
2.Complications associated with each technique  intra-operative and post-operative till patient is discharged from ICU 
Clinical outcome assessment:
a)Total inotropic score
b)Number of shock if needed
c)Arrhythmia if noted
d)Morbidity and mortality after risk adjustment
 
Intra-operative and post-operative till patient is discharged from ICU 
 
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)   01/06/2022 
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)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Perioperative cardiac function monitoring plays a crucial role in the assessment, treatment, and prognosis of patients undergoing cardiac surgery of which Cardiac output (CO) measurement is one of the most important parameters.

Pulmonary artery catheter (PAC) is used to measure CO by thermodilution (TD) technique and is still considered as gold standard method since 1970s when it was first introduced by Dexter et al and further modified by William Ganz et al.

PAC is invasive and is associated with numerous complications like pneumothorax, arrhythmia, infection, pulmonary artery rupture, valve injury, knotting and thrombo-embolism. It is prone to technical errors due to loss of injectate, temperature variability, thermistor malfunction, coiling of catheter or variability in timing of injectate. Intracardiac shunts, mechanical ventilation and valvular dysfunction may lead to incorrect interpretation. This led to the development of less invasive methods of CO monitoring such as Echocardiography, thoracic electrical bioimpedance, and magnetic resonance imaging, arterial wave contour analysis, PiCCO, transpulmonary thermodilution, transpulmonary lithium dilution which have questionable benefits during open-heart cardiovascular surgery.

Trans-esophageal echocardiography (TEE) allows both cardiac structure and functions evaluation. Valvular pathology can also be detected by it. However, it requires training and skills by the operator and has a higher cost. Certain requirements must be fulfilled: (a) the absence of turbulence (b) parallel orientation of the Doppler beam to the direction of the blood flow in the left ventricle outflow tract (LVOT) and aortic valve. Various routes for CO measurements are: at the level of pulmonary artery (PA), mitral valve (MV) or aortic valve (AV) and at left ventricular outflow tract (LVOT) with pulsed wave doppler (PWD) and continuous wave doppler (CWD).

It has been observed that use of PAC in elective coronary artery bypass graft (CABG) surgery increases patients risk adjusted mortality and morbidity. In addition, TEE provides cause of low CO, hemodynamic instability and other associated lesions such as aortic pathology. TEE has been shown to improve mortality. Hence, if CO measurement by PAC and TEE are comparable or if TEE method is superior, use of PAC can be avoided in CABG patients. With lesser complications than PA catheter based thermodilution techniques, we would like to assess if TEE based CO measurement can be interchanged with the latter in patients undergoing off pump coronary artery bypass graft (OPCAB) as use of TEE is recommended (Class I) for intra-operative monitoring of CABG patients.

Lacunae in existing knowledge:

Whether echocardiography can replace thermodilution method in CO measurement still remains controversial. Certain studies including systematic reviews and meta-analysis show good correlation between TEE and TD while others have concluded TEE cannot be interchanged with TD and have suggested further evaluation. The accuracy of CO measurement using TEE has not been adequately validated, especially in CABG surgeries.

 
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