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

Coronary Artery Disease Clinical Trial

— Strecho-O2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424433
• Other study ID #: 2020-00145
• Secondary ID: SNCTP000003911
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: June 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Disease
• Coronary Disease
• Hyperoxia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Bern University Hospital, Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View Citation

Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Gräni C, von Tengg-Kobligk H, Räber 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. — View 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. — View 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. Erratum in: Perioper Med (Lond). 2018 Oct 24;7:26. South Coast Perioperative Audit and Research Collaboration (SPARC) [added]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in myocardial peak strain between oxygen levels	Percent (%), a measure of systolic function (shortening and thickening) of the myocardium	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial time to peak strain between oxygen levels	Milliseconds (ms)	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial strain rate between oxygen levels	Change in strain over time (/second)	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial strain rate ratio between oxygen levels	Change in E/A ratio	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial displacement between oxygen levels	Millimeters (mm)	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial time to peak displacement between oxygen levels	Milliseconds (ms)	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial velocities between oxygen levels	Change in displacement over time (millimeters/second)	Through study completion, within 1hour post-induction
Secondary	Difference in myocardial velocity ratio between oxygen levels	Change in E/A ratio	Through study completion, within 1hour post-induction
Secondary	Difference in peak twist	Degrees (°)	Through study completion, within 1hour post-induction
Secondary	Difference in peak torsion	Degrees/centimeter (°/cm)	Through study completion, within 1hour post-induction
Secondary	Difference in ejection fraction (EF)	Percent (%)	Through study completion, within 1hour post-induction
Secondary	Difference in chamber volumes	Millilitres (ml)	Through study completion, within 1hour post-induction