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Completed

NCT Number: NCT04424433

Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bern University Hospital, Inselspital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.

Other names: Medical gas

Primary outcomes

  1. 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

Secondary outcomes

  1. Difference in myocardial time to peak strain between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Milliseconds (ms)

  2. Difference in myocardial strain rate between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Change in strain over time (/second)

  3. Difference in myocardial strain rate ratio between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Change in E/A ratio

  4. Difference in myocardial displacement between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Millimeters (mm)

  5. Difference in myocardial time to peak displacement between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Milliseconds (ms)

  6. Difference in myocardial velocities between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Change in displacement over time (millimeters/second)

  7. Difference in myocardial velocity ratio between oxygen levels

    Time frame: Through study completion, within 1hour post-induction

    Change in E/A ratio

  8. Difference in peak twist

    Time frame: Through study completion, within 1hour post-induction

    Degrees (°)

  9. Difference in peak torsion

    Time frame: Through study completion, within 1hour post-induction

    Degrees/centimeter (°/cm)

  10. Difference in ejection fraction (EF)

    Time frame: Through study completion, within 1hour post-induction

    Percent (%)

  11. Difference in chamber volumes

    Time frame: Through study completion, within 1hour post-induction

    Millilitres (ml)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: Strecho-O₂

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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