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The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients undergoing non-cardiac vascular surgery.
Up to 110 patients with either proven coronary artery disease (CAD) or two or more risk factors for CAD undergoing elective or non-emergent non-cardiac vascular surgery will be recruited. Three blood samples for levels of myocardial biomarkers will be obtained at different perioperative time points (before anaesthesia induction, 2 hours after skin closure and 24 hours after the end of the surgery). The three myocardial biomarkers investigated are high-sensitive Troponin T (hsTnT), N-terminal (NT)-pro hormone BNP (NT-proBNP) and heart-type fatty acid binding protein (H-FABP). 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 patients are again randomly assigned to either the normoxaemic or the hyperoxic state for the remainder of the perioperative treatment until 2 hours after skin closure. Surgery will be performed as planned by the treating team. Differences in the perioperative levels of myocardial biomarkers at the different time points and their dynamics will be assessed. 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 + Hyperoxia Procedure | Experimental | Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second. After the image acquisition patients receive hyperoxic concentrations. |
|
| Normoxaemia First + Normoxia Procedure | Experimental | Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second. After the image acquisition patients receive normoxic concentrations. |
|
| Hyperoxia First + Hyperoxia Procedure | Experimental | Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second. After the image acquisition patients receive hyperoxic concentrations. |
|
| Hyperoxia First + Normoxaemia Procedure | Experimental | Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second. After the image acquisition patients receive normoxic concentrations. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in hsTnT from preoperative baseline | ng/L | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of myocardial injury in non-cardiac surgery (MINS) | MINS is defined as an absolute change of hsTnT levels of at least 5ng/L from preoperative baseline or an hs-TnT level of at least 65ng/L | at 24 hours after surgery |
| Difference in high sensitive TnT from preoperative baseline |
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Inclusion Criteria:
or
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominik P Guensch, MD | Contact | +41 31 632 03 77 | dominik.guensch@insel.ch | |
| Jan-Oliver Friess, MD | Contact | +41 31 632 39 65 | jan-oliver.friess@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Dominik P Guensch, MD | Bern University Hospital, Inselspital | Principal Investigator |
| Jan-Oliver Friess, MD | Bern University Hospital, Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bern University Hospital, Inselspital | Recruiting | 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. | |
| 31095334 |
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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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Patients start with a crossover design undergoing both TEE images at normoxia and hyperoxia in random order and then are randomized a second time to receive either normoxia or hyperoxia for the remaining procedure in a parallel design.
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TEE images will be coded and analysed in batches at a later date by a blinded reader
|
ng/L |
| at 2 hours after surgery |
| Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline | pg/ml | at 2 hours and 24 hours after surgery |
| Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline | pg/ml | at 2 hours and 24 hours after surgery |
| 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 | 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 |
| Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301. |
| 37588173 | Background | 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 |