๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
Bern University Hospital, Inselspital
Bern, Switzerland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.