Bern University Hospital, Inselspital
Bern, 3010, Switzerland
NCT Number: NCT04424433
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
Other names: Medical gas
Time frame: Through study completion, within 1hour post-induction
Percent (%), a measure of systolic function (shortening and thickening) of the myocardium
Time frame: Through study completion, within 1hour post-induction
Milliseconds (ms)
Time frame: Through study completion, within 1hour post-induction
Change in strain over time (/second)
Time frame: Through study completion, within 1hour post-induction
Change in E/A ratio
Time frame: Through study completion, within 1hour post-induction
Millimeters (mm)
Time frame: Through study completion, within 1hour post-induction
Milliseconds (ms)
Time frame: Through study completion, within 1hour post-induction
Change in displacement over time (millimeters/second)
Time frame: Through study completion, within 1hour post-induction
Change in E/A ratio
Time frame: Through study completion, within 1hour post-induction
Degrees (°)
Time frame: Through study completion, within 1hour post-induction
Degrees/centimeter (°/cm)
Time frame: Through study completion, within 1hour post-induction
Percent (%)
Time frame: Through study completion, within 1hour post-induction
Millilitres (ml)
Insel Gruppe AG, University Hospital Bern
Other
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
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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