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

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Completed
• CT.gov ID: NCT04424433
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.1
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Anesthesia	Drug: Oxygen	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: TEE images will be coded and analysed in batches at a later date by a blinded reader
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jun 4, 2021
• Actual Study Completion Date: Jun 4, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference in myocardial peak strain between oxygen levels [Through study completion, within 1hour post-induction]

   Percent (%), a measure of systolic function (shortening and thickening) of the myocardium

Secondary Outcome Measures

1. Difference in myocardial time to peak strain between oxygen levels [Through study completion, within 1hour post-induction]

   Milliseconds (ms)

2. Difference in myocardial strain rate between oxygen levels [Through study completion, within 1hour post-induction]

   Change in strain over time (/second)

3. Difference in myocardial strain rate ratio between oxygen levels [Through study completion, within 1hour post-induction]

   Change in E/A ratio

4. Difference in myocardial displacement between oxygen levels [Through study completion, within 1hour post-induction]

   Millimeters (mm)

5. Difference in myocardial time to peak displacement between oxygen levels [Through study completion, within 1hour post-induction]

   Milliseconds (ms)

6. Difference in myocardial velocities between oxygen levels [Through study completion, within 1hour post-induction]

   Change in displacement over time (millimeters/second)

7. Difference in myocardial velocity ratio between oxygen levels [Through study completion, within 1hour post-induction]

   Change in E/A ratio

8. Difference in peak twist [Through study completion, within 1hour post-induction]

   Degrees (°)

9. Difference in peak torsion [Through study completion, within 1hour post-induction]

   Degrees/centimeter (°/cm)

10. Difference in ejection fraction (EF) [Through study completion, within 1hour post-induction]

    Percent (%)

11. Difference in chamber volumes [Through study completion, within 1hour post-induction]

    Millilitres (ml)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bern University Hospital, Inselspital	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

• Principal Investigator: Dominik P Guensch, MD, Bern University Hospital, Inselspital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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].

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT04424433
• Other Study ID Numbers: 2020-00145; SNCTP000003911
• First Posted: Jun 11, 2020
• Last Update Posted: Jun 9, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: Coronary artery disease; Transesophageal Echocardiography (TEE); Hyperoxia; Strain; Myocardial Deformation; Anaesthesia; CABG; Normoxaemia
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperoxia

Study Results

No Results Posted as of Jun 9, 2021