Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia (Strecho-O₂)

June 8, 2021 updated by: University Hospital Inselspital, Berne

Myocardial Strain Analysis in Patients With Coronary Artery Disease at Hyperoxia and Normoxaemia Prior to Coronary Artery Bypass Graft Surgery - a Randomized Crossover Study

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

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

  • Switzerland
      • Bern, Switzerland, 3010
        • Bern University Hospital, Inselspital

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

Description

Inclusion Criteria:

  • Elective CABG surgery (with or without other cardiac surgery)
  • Ability to give and sign informed consent
  • Age >18 years.

Exclusion Criteria:

  • Absolute contraindication for TEE
  • Emergency surgery, including but not limited to patients with instable CAD: ST- and Non-ST-elevation myocardial infarction (STEMI, NSTEMI) and instable angina (instable AP)
  • Atrial fibrillation or significant arrhythmia
  • Pacemaker, CRT, left bundle branch block
  • Severe-grade valvular disease
  • Pericardial disease
  • Previous cardiac or thoracic aortic surgery
  • Previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy
  • Severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e., where high FIO2 might reduce pulmonary vascular resistance and right ventricular afterload
  • Patients where study explanation and informed consent cannot been performed/obtained at the latest on the day before scheduled surgery
  • Females of child-bearing potential

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Normoxaemia First
Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
Drug: Oxygen
Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
Other Names:
  • Medical gas
Other: Hyperoxia First
Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
Drug: Oxygen
Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
Other Names:
  • Medical gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in myocardial peak strain between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Percent (%), a measure of systolic function (shortening and thickening) of the myocardium
Through study completion, within 1hour post-induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in myocardial time to peak strain between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Milliseconds (ms)
Through study completion, within 1hour post-induction
Difference in myocardial strain rate between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Change in strain over time (/second)
Through study completion, within 1hour post-induction
Difference in myocardial strain rate ratio between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Change in E/A ratio
Through study completion, within 1hour post-induction
Difference in myocardial displacement between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Millimeters (mm)
Through study completion, within 1hour post-induction
Difference in myocardial time to peak displacement between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Milliseconds (ms)
Through study completion, within 1hour post-induction
Difference in myocardial velocities between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Change in displacement over time (millimeters/second)
Through study completion, within 1hour post-induction
Difference in myocardial velocity ratio between oxygen levels
Time Frame: Through study completion, within 1hour post-induction
Change in E/A ratio
Through study completion, within 1hour post-induction
Difference in peak twist
Time Frame: Through study completion, within 1hour post-induction
Degrees (°)
Through study completion, within 1hour post-induction
Difference in peak torsion
Time Frame: Through study completion, within 1hour post-induction
Degrees/centimeter (°/cm)
Through study completion, within 1hour post-induction
Difference in ejection fraction (EF)
Time Frame: Through study completion, within 1hour post-induction
Percent (%)
Through study completion, within 1hour post-induction
Difference in chamber volumes
Time Frame: Through study completion, within 1hour post-induction
Millilitres (ml)
Through study completion, within 1hour post-induction

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2020

Primary Completion (Actual)

June 4, 2021

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00145
  • SNCTP000003911 (Other Identifier: Swiss National Clinical Trials Portal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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