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

Primary Purpose

Coronary Artery Disease, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring Coronary artery disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial Deformation, Anaesthesia, CABG, Normoxaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bern University Hospital, Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Normoxaemia First

Hyperoxia First

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in myocardial peak strain between oxygen levels
Percent (%), a measure of systolic function (shortening and thickening) of the myocardium

Secondary Outcome Measures

Difference in myocardial time to peak strain between oxygen levels
Milliseconds (ms)
Difference in myocardial strain rate between oxygen levels
Change in strain over time (/second)
Difference in myocardial strain rate ratio between oxygen levels
Change in E/A ratio
Difference in myocardial displacement between oxygen levels
Millimeters (mm)
Difference in myocardial time to peak displacement between oxygen levels
Milliseconds (ms)
Difference in myocardial velocities between oxygen levels
Change in displacement over time (millimeters/second)
Difference in myocardial velocity ratio between oxygen levels
Change in E/A ratio
Difference in peak twist
Degrees (°)
Difference in peak torsion
Degrees/centimeter (°/cm)
Difference in ejection fraction (EF)
Percent (%)
Difference in chamber volumes
Millilitres (ml)

Full Information

First Posted
June 2, 2020
Last Updated
June 8, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04424433
Brief Title
Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anesthesia
Keywords
Coronary artery disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial Deformation, Anaesthesia, CABG, Normoxaemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
TEE images will be coded and analysed in batches at a later date by a blinded reader
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normoxaemia First
Arm Type
Other
Arm Description
Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
Arm Title
Hyperoxia First
Arm Type
Other
Arm Description
Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
Medical gas
Intervention Description
Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
Primary Outcome Measure Information:
Title
Difference in myocardial peak strain between oxygen levels
Description
Percent (%), a measure of systolic function (shortening and thickening) of the myocardium
Time Frame
Through study completion, within 1hour post-induction
Secondary Outcome Measure Information:
Title
Difference in myocardial time to peak strain between oxygen levels
Description
Milliseconds (ms)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial strain rate between oxygen levels
Description
Change in strain over time (/second)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial strain rate ratio between oxygen levels
Description
Change in E/A ratio
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial displacement between oxygen levels
Description
Millimeters (mm)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial time to peak displacement between oxygen levels
Description
Milliseconds (ms)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial velocities between oxygen levels
Description
Change in displacement over time (millimeters/second)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial velocity ratio between oxygen levels
Description
Change in E/A ratio
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in peak twist
Description
Degrees (°)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in peak torsion
Description
Degrees/centimeter (°/cm)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in ejection fraction (EF)
Description
Percent (%)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in chamber volumes
Description
Millilitres (ml)
Time Frame
Through study completion, within 1hour post-induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik P Guensch, MD
Organizational Affiliation
Bern University Hospital, Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bern University Hospital, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32089047
Citation
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.
Results Reference
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PubMed Identifier
26405156
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.
Results Reference
background
PubMed Identifier
30685156
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. No abstract available.
Results Reference
background
PubMed Identifier
30770050
Citation
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.
Results Reference
background
PubMed Identifier
30062007
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].
Results Reference
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Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia

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