Impact of Oxygen Levels on Heart Function During Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.