- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692131
Comparison of Two Methods of Strain by Perioperative Transesophageal Echo in CABG : An Observational Study (Strain)
Comparison of Two Different Methods of Obtaining Strain by Perioperative Transesophageal in Patients Undergoing Coronary Artery Bypass Grafting : An Observational Study
Study Overview
Status
Conditions
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:
- 2 dimensional Left ventricular ejection fraction using Simpson's method from midesophageal 4 chamber and midesophageal 2 chamber views.
- 3 dimensional Left ventricular ejection fraction from midesophageal 4 chamber and midesophageal 2 chamber views.
- Doppler tissue imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chandigarh, India, 160012
- PGIMER
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 18 yrs
- On pump CABG
Exclusion Criteria:
- < 18 yrs
- other on pump cardiac surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Speckle strain
All adult patients undergoing on pump CABG Surgery.
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Tissue doppler strain
All adult patients undergoing on pump CABG Surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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Intraoperatively before going on bypass and 30 mins after coming off bypass.
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Collaborators and Investigators
Investigators
- Study Chair: Banashree mandal, MD, DM, Postgraduate Institute of Medical Education and Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NK/2496/study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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