Clinical trial NCT04424433: Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Anesthesia
Keywords: Coronary artery disease
Transesophageal Echocardiography (TEE)
Hyperoxia
Strain
Myocardial Deformation
Anaesthesia
CABG
Normoxaemia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in myocardial peak strain between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
Secondary outcomes:
measure: Difference in myocardial time to peak strain between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial strain rate between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial strain rate ratio between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial displacement between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial time to peak displacement between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial velocities between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in myocardial velocity ratio between oxygen levels
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in peak twist
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in peak torsion
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in ejection fraction (EF)
timeFrame: Through study completion, within 1hour post-induction
measure: Difference in chamber volumes
timeFrame: Through study completion, within 1hour post-induction
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital, Inselspital
Study officials:
affiliation: Bern University Hospital, Inselspital
name: Dominik P Guensch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.
citation: Guensch DP, Fischer K, Shie N, Lebel J, Friedrich MG. Hyperoxia Exacerbates Myocardial Ischemia in the Presence of Acute Coronary Artery Stenosis in Swine. Circ Cardiovasc Interv. 2015 Oct;8(10):e002928. doi: 10.1161/CIRCINTERVENTIONS.115.002928.
citation: Guensch DP, Friess JO, Eberle B, Erdoes G. Hyperoxia-a Wolf in Sheep's Clothing? J Cardiothorac Vasc Anesth. 2019 May;33(5):1179-1180. doi: 10.1053/j.jvca.2018.12.024. Epub 2018 Dec 27. No abstract available.
citation: de Jonge S, Egger M, Latif A, Loke YK, Berenholtz S, Boermeester M, Allegranzi B, Solomkin J. Effectiveness of 80% vs 30-35% fraction of inspired oxygen in patients undergoing surgery: an updated systematic review and meta-analysis. Br J Anaesth. 2019 Mar;122(3):325-334. doi: 10.1016/j.bja.2018.11.024. Epub 2019 Jan 6.
citation: Morkane CM, McKenna H, Cumpstey AF, Oldman AH, Grocott MPW, Martin DS; Pan London Perioperative Audit and Research Network (PLAN); South Coast Perioperative Audit and Research Collaboration (SPARC). Intraoperative oxygenation in adult patients undergoing surgery (iOPS): a retrospective observational study across 29 UK hospitals. Perioper Med (Lond). 2018 Jul 24;7:17. doi: 10.1186/s13741-018-0098-3. eCollection 2018.