Comparison of Two Methods of Strain by Perioperative Transesophageal Echo in CABG : An Observational Study (Strain)

September 27, 2016 updated by: Dr Alok Kumar, Postgraduate Institute of Medical Education and Research

Comparison of Two Different Methods of Obtaining Strain by Perioperative Transesophageal in Patients Undergoing Coronary Artery Bypass Grafting : An Observational Study

There is an increasing need for diagnostic modalities able to objectively quantify myocardial function. Quantification of regional myocardial function with ultrasound is challenging on its own. Visual assessment of wall motion and thickening requires extensive training [1] and remains highly subjective [2]. Tissue deformation imaging is a recently introduced technique which enables the objective assessment of regional myocardial deformation assessed by ultrasound based strain and strain rate using Doppler Tissue Imaging or Speckle tracking. There are limited number of studies comparing the myocardial deformation parameters (i.e. Strain and Strain rate) by 2 different echocardiographic techniques viz Doppler tissue imaging and Speckle tracking in the perioperative period. In this study, we plan to study the above said parameters in patients undergoing coronary artery bypass grafting using transesophageal echocardiography and correlate these parameters with cardiac output by thermodilution method using pulmonary artery catheter.

Study Overview

Status

Completed

Detailed Description

The study will be conducted in the Department of Anaesthesiology and Intensive Care, Advanced Cardiac Centre, Post Graduate Institute Medical Education Research, Chandigarh after obtaining institutional ethical committee clearance. Fifty patients scheduled for coronary artery bypass grafting (CABG) will be included in the study. An informed written consent will be taken from all the patients.

Anaesthesia technique All patients will be examined a day prior to surgery. Baseline data including preoperative physical status, haemogram, biochemistry, preoperative transthoracic echocardiography and coronary angiography data will be noted. A standard anaesthesia technique will be used for all the patients. Inside the operating room, electrocardiography (ECG), pulse oximetry and noninvasive blood pressure (NIBP) will be applied. Anaesthesia will be induced with fentanyl 5 - 10 µg/kg/ body weight and propofol titrated to loss of response to verbal commands followed by endotracheal intubation facilitated by vecuronium 0.1mg/kg. A 20 gauge arterial catheter will be inserted in left radial artery and right internal jugular vein will be cannulated with triple lumen catheter for central venous access and pulmonary artery catheter for haemodynamic assessment. A baseline transthoracic echocardiogram will be performed after induction of general anaesthesia. After induction of general anaesthesia , a TEE probe (GE Medical Systems, Horten, Norway) will be introduced. Anaesthesia will be maintained by isoflurane, intravenous morphine (intermittent boluses; total 0.5 mg/kg during surgery) and vecuronium boluses. All patients will undergo CABG under cardiopulmonary bypass (CPB) support. Total cardiopulmonary bypass time and Aortic cross clamp time will be noted. Patients will be shifted to cardiac surgical intensive care unit (ICU) and electively ventilated. Decision on extubation and inotrope support will be left to attending intensivist.

Echocardiography data After induction of general anaesthesia, a comprehensive transesophageal echocardiogram will be performed using probe of the GE vivid E9 echocardiography system (GE Medical Systems, Hortein, Norway) in all the patients.

The following parameters will be noted before instituting CPB and after weaning from CPB and achievement of stable haemodynamics:

  1. 2 dimensional Left ventricular ejection fraction using Simpson's method from midesophageal 4 chamber and midesophageal 2 chamber views.
  2. 3 dimensional Left ventricular ejection fraction from midesophageal 4 chamber and midesophageal 2 chamber views.
  3. Doppler tissue imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
  4. Speckle track imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.

An average of 3 readings over 3 different cardiac cycles will be used for above parameters.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chandigarh, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult (> 18 yrs) patients undergoing on pump CABG.

Description

Inclusion Criteria:

  • > 18 yrs
  • On pump CABG

Exclusion Criteria:

  • < 18 yrs
  • other on pump cardiac surgery

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Speckle strain
All adult patients undergoing on pump CABG Surgery.
Tissue doppler strain
All adult patients undergoing on pump CABG Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between left ventricle strain measured by Doppler tissue imaging and speckle tracking using transesophageal echocardiography in patients undergoing coronary artery bypass surgery.
Time Frame: Intraoperatively before going on bypass and 30 mins after coming off bypass.
Intraoperatively before going on bypass and 30 mins after coming off bypass.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Banashree mandal, MD, DM, Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

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