| 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
|
|
|
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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
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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.
|
|
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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 |
|
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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. |