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

NCT04424433 | Completed

• 2 other identifiers: 2020-00145SNCTP000003911
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Anesthesia

Keywords

Coronary artery disease; Transesophageal Echocardiography (TEE); Hyperoxia; Strain; Myocardial Deformation; Anaesthesia; CABG; Normoxaemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Difference in myocardial time to peak strain between oxygen levels

  Through study completion, within 1hour post-induction

• Difference in myocardial strain rate between oxygen levels

  Through study completion, within 1hour post-induction

• Difference in myocardial strain rate ratio between oxygen levels

  Through study completion, within 1hour post-induction

• Difference in myocardial displacement between oxygen levels

  Through study completion, within 1hour post-induction

• Difference in myocardial time to peak displacement between oxygen levels

  Through study completion, within 1hour post-induction

Study Arms (2)

Normoxaemia First

OTHER

Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.

Drug: Oxygen

Hyperoxia First

OTHER

Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.

Drug: Oxygen

Interventions

Oxygen DRUG

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

Also known as: Medical gas

Hyperoxia First; Normoxaemia First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective CABG surgery (with or without other cardiac surgery)
• Ability to give and sign informed consent
• Age \>18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 32089047 BACKGROUND

• 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.

  PMID: 26405156 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.

  PMID: 30685156 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.

  PMID: 30770050 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.

  PMID: 30062007 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.

  PMID: 37588173 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Hyperoxia; Sprains and Strains

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Dominik P Guensch, MD

  Bern University Hospital, Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: TEE images will be coded and analysed in batches at a later date by a blinded reader
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

CH (1)