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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000003911 | Other Identifier | Swiss National Clinical Trials Portal |
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The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxaemia First | Other | Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second. |
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| Hyperoxia First | Other | Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in myocardial time to peak strain between oxygen levels | Milliseconds (ms) | Through study completion, within 1hour post-induction |
| Difference in myocardial strain rate between oxygen levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominik P Guensch, MD | Bern University Hospital, Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bern University Hospital, Inselspital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32089047 | Background | 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. | |
| 26405156 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D018496 | Hyperoxia |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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TEE images will be coded and analysed in batches at a later date by a blinded reader
|
Change in strain over time (/second)
| Through study completion, within 1hour post-induction |
| Difference in myocardial strain rate ratio between oxygen levels | Change in E/A ratio | Through study completion, within 1hour post-induction |
| Difference in myocardial displacement between oxygen levels | Millimeters (mm) | Through study completion, within 1hour post-induction |
| Difference in myocardial time to peak displacement between oxygen levels | Milliseconds (ms) | Through study completion, within 1hour post-induction |
| Difference in myocardial velocities between oxygen levels | Change in displacement over time (millimeters/second) | Through study completion, within 1hour post-induction |
| Difference in myocardial velocity ratio between oxygen levels | Change in E/A ratio | Through study completion, within 1hour post-induction |
| Difference in peak twist | Degrees (°) | Through study completion, within 1hour post-induction |
| Difference in peak torsion | Degrees/centimeter (°/cm) | Through study completion, within 1hour post-induction |
| Difference in ejection fraction (EF) | Percent (%) | Through study completion, within 1hour post-induction |
| Difference in chamber volumes | Millilitres (ml) | Through study completion, within 1hour post-induction |
| 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. |
| 30685156 | Background | 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. |
| 30770050 | Background | 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. |
| 30062007 | Background | 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. |
| 41919002 | Derived | Friess JO, Laederach T, Milani GM, Anja L, Terbeck S, Huber M, Gerber D, Erdoes G, Schoenhoff FS, Madhkour R, Fischer K, Guensch DP. Effects of hyperoxia on systolic and diastolic function assessed by strain analysis in patients with coronary artery disease during general anaesthesia. Eur J Anaesthesiol Intensive Care. 2026 Mar 4;5(2):e0101. doi: 10.1097/EA9.0000000000000101. eCollection 2026 Apr. |
| 37588173 | Derived | Friess JO, Mikasi J, Baumann R, Ranjan R, Fischer K, Levis A, Terbeck S, Hirschi T, Gerber D, Erdoes G, Schoenhoff FS, Carrel TP, Madhkour R, Eberle B, Guensch DP. Hyperoxia-induced deterioration of diastolic function in anaesthetised patients with coronary artery disease - Randomised crossover trial. BJA Open. 2023 Apr 27;6:100135. doi: 10.1016/j.bjao.2023.100135. eCollection 2023 Jun. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |