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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Inselspital, Berne

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