Impact of Oxygen Levels on Heart Function During Surgery
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
This study is testing whether giving higher or normal oxygen levels during surgery can affect heart function in patients with coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bern) |
| Trial ID | NCT04808401 on ClinicalTrials.gov |
What this trial studies
This study investigates how different levels of oxygen (hyperoxia vs normoxia) affect heart function in patients with coronary artery disease undergoing elective non-cardiac vascular surgery. Up to 110 patients will be recruited and monitored for changes in myocardial biomarkers and cardiac strain using transesophageal echocardiography at various points during the perioperative period. Patients will be randomized to receive either a higher or normal level of oxygen during their surgery, and the effects on heart function will be assessed through blood samples and echocardiography measurements.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective non-cardiac vascular surgery who have proven coronary artery disease or multiple risk factors for it.
Not a fit: Patients with recent acute coronary events, severe arrhythmias, or significant pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved perioperative outcomes and heart protection strategies for patients with coronary artery disease undergoing surgery.
How similar studies have performed: While the specific approach of manipulating oxygen levels in this context may be novel, similar studies have shown promising results in improving cardiac outcomes in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Where this trial is running
Bern
- Bern University Hospital, Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Dominik P Guensch, MD — Bern University Hospital, Inselspital
- Study coordinator: Dominik P Guensch, MD
- Email: dominik.guensch@insel.ch
- Phone: +41 31 632 03 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.