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Coronary Artery DiseaseStrecho-O₂NCT04424433

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

A study testing Oxygen in people with Coronary Artery Disease and Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Anesthesia
What is being tested?
Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteSwitzerland
Study dates
1 Jun 2020to 4 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Bern University Hospital, Inselspital

    Bern, 3010

Other trials in Switzerland

About this study

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

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

Read the 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.

Being tested
Oxygen
Keywords
Coronary artery disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial Deformation, Anaesthesia, CABG, Normoxaemia
Medical subject headings
Coronary Artery Disease, Hyperoxia, Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    Also called Medical gas

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

Study groups in NCT04424433
Study groupRoleWhat they receive
Normoxaemia FirstOtherPatients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
Receives: Drug: Oxygen
Hyperoxia FirstOtherPatients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
Receives: Drug: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in myocardial peak strain between oxygen levels

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

    Measured: Through study completion, within 1hour post-induction

Secondary outcomes (11)

  1. Difference in myocardial time to peak strain between oxygen levels

    Milliseconds (ms)

    Measured: Through study completion, within 1hour post-induction

  2. Difference in myocardial strain rate between oxygen levels

    Change in strain over time (/second)

    Measured: Through study completion, within 1hour post-induction

  3. Difference in myocardial strain rate ratio between oxygen levels

    Change in E/A ratio

    Measured: Through study completion, within 1hour post-induction

  4. Difference in myocardial displacement between oxygen levels

    Millimeters (mm)

    Measured: Through study completion, within 1hour post-induction

  5. Difference in myocardial time to peak displacement between oxygen levels

    Milliseconds (ms)

    Measured: Through study completion, within 1hour post-induction

  6. Difference in myocardial velocities between oxygen levels

    Change in displacement over time (millimeters/second)

    Measured: Through study completion, within 1hour post-induction

  7. Difference in myocardial velocity ratio between oxygen levels

    Change in E/A ratio

    Measured: Through study completion, within 1hour post-induction

  8. Difference in peak twist

    Degrees (°)

    Measured: Through study completion, within 1hour post-induction

  9. Difference in peak torsion

    Degrees/centimeter (°/cm)

    Measured: Through study completion, within 1hour post-induction

  10. Difference in ejection fraction (EF)

    Percent (%)

    Measured: Through study completion, within 1hour post-induction

  11. Difference in chamber volumes

    Millilitres (ml)

    Measured: Through study completion, within 1hour post-induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion4 Jun 2021
  4. Study completion4 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04424433
Sponsor's protocol ID
2020-00145
Other IDs
SNCTP000003911
Acronym
Strecho-O₂
Status last verified
Jun 2021
First submitted
2 Jun 2020
Last updated
9 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32089047

  • 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.

    PubMed 26405156

  • 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.

    PubMed 30685156

  • 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.

    PubMed 30770050

  • 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.

    PubMed 30062007

  • 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.

    PubMed 41919002

  • 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.

    PubMed 37588173

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen in people with Coronary Artery Disease and Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in myocardial peak strain between oxygen levels (time frame: Through study completion, within 1hour post-induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04424433, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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