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Coronary Artery DiseasePromise-O2NCT04808401

Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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 undergoing non-cardiac vascular surgery. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
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
110 participants
Where
1 siteSwitzerland
Study dates
7 May 2021to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Patients eligible for the study should be scheduled for elective or non-emergent non-cardiac vascular surgery under general anaesthesia with endotracheal intubation, and have either
  • proven CAD and will undergo high- or intermediate surgical risk procedure according to European (European Society of Cardiology, ESC / European Society of Anaesthesiology and Intensive Care, ESAIC) guidelines on non-cardiac surgery.
  • or
  • two or more risk factors for CAD and will undergo high- or intermediate surgical risk procedures according to European ESC/ESAIC guidelines on non-cardiac surgery.

Who cannot join

  • Acute coronary event 30 days before surgery
  • Acute congestive heart failure
  • Hemodynamic instability before induction of aneasthesia (vasopressor or inotrope infusion since hospitalization for index surgery)
  • Atrial fibrillation or other severe arrhythmia
  • Severe pulmonary disease (dependent on oxygen therapy or the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 or severe carbon monoxide diffusion impairment or severe pulmonary hypertension)
  • Preoperative oxygen saturation (SpO2) below 90% on room air
Show all 15Show fewer
  • Increased risk of oxygen toxicity (e.g., chemotherapy for malignancy within 3 months, bleomycin treatment, airway laser surgery)
  • Scheduled surgery in the thoracic cavity
  • ICU admission for respirator weaning and delayed extubation
  • Pre-existing surgical site infection (SSI)
  • Current active signs of systemic inflammatory response syndrome (SIRS) or sepsis according The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
  • Pregnancy
  • Emergency surgery (to be performed within less than 12 hours of scheduling)
  • Ambulatory surgery
  • Baseline hs-TnT level elevated above 65ng/L

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Switzerland1 site, 1 recruiting

  • Bern University Hospital, Inselspital

    Bern, 3010

    Dominik P Guensch, MD, +41 31 632 03 77, dominik.guensch@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Influence of Different Inspired Oxygen Fractions on Perioperative Myocardial Biomarkers, Myocardial Strain and Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery: A Prospective Randomized Open-label Single Centre Pilot Study

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.

Read the detailed description

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.

Being tested
Oxygen
Keywords
Coronary Artery Disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial biomarkers, Normoxaemia, Anaesthesia
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 NCT04808401
Study groupRoleWhat they receive
Normoxaemia First + Hyperoxia ProcedureExperimentalPatients 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.
Receives: Drug: Oxygen
Normoxaemia First + Normoxia ProcedureExperimentalPatients 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.
Receives: Drug: Oxygen
Hyperoxia First + Hyperoxia ProcedureExperimentalPatients 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.
Receives: Drug: Oxygen
Hyperoxia First + Normoxaemia ProcedureExperimentalPatients 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.
Receives: Drug: Oxygen

What is being measured

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

  1. Difference in hsTnT from preoperative baseline

    ng/L

    Measured: at 24 hours after surgery

Secondary outcomes (15)

  1. 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

    Measured: at 24 hours after surgery

  2. Difference in high sensitive TnT from preoperative baseline

    ng/L

    Measured: at 2 hours after surgery

  3. Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline

    pg/ml

    Measured: at 2 hours and 24 hours after surgery

  4. Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline

    pg/ml

    Measured: at 2 hours and 24 hours after surgery

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

    Milliseconds (ms)

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

  6. Difference in myocardial strain rate between oxygen levels

    Change in strain over time (/second)

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

  7. Difference in myocardial strain rate ratio between oxygen levels

    Change in E/A ratio

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

  8. Difference in myocardial displacement between oxygen levels

    Millimeters (mm)

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

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

    Milliseconds (ms)

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

  10. Difference in myocardial velocities between oxygen levels

    Change in displacement over time (millimeters/second)

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

  11. Difference in myocardial velocity ratio between oxygen levels

    Change in E/A ratio

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

  12. Difference in peak twist

    Degrees (°)

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

  13. Difference in peak torsion

    Degrees/centimeter (°/cm)

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

  14. Difference in ejection fraction (EF)

    Percent (%)

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

  15. 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 posted22 Mar 2021
  2. Study start7 May 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

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
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808401
Sponsor's protocol ID
2020_02560
Acronym
Promise-O2
Status last verified
Dec 2024
First submitted
15 Mar 2021
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

  • 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.

    PubMed 31095334

  • 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Dominik P Guensch, MD (+41 31 632 03 77, dominik.guensch@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in hsTnT from preoperative baseline (time frame: at 24 hours after surgery). 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 NCT04808401, which also lists 3 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 13 Dec 2024.

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