Testing Oxygen Levels During Anaesthesia for Non-cardiac Surgery
Tests how high oxygen levels affect heart function in adults having surgery under general anaesthesia.
Plain-language title generated from the registry record
Registry title: Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
Key facts
- Where
- Bern, SwitzerlandSee the site
Where in Switzerland
- Bern University Hospital, InselspitalBern, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT04808401
- Record updated
- 13 December 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Acute coronary event 30 days before surgery; Hemodynamic instability before induction of aneasthesia (vasopressor or inotrope infusion since hospitalization for index surgery); Scheduled surgery in the thoracic cavity; Emergency surgery (to be performed within less than 12 hours of scheduling); Ambulatory surgery; Acute congestive heart failure; 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); Increased risk of oxygen toxicity (e.g., chemotherapy for malignancy within 3 months, bleomycin treatment, airway laser surgery); 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); Preoperative oxygen saturation (SpO2) below 90% on room air; ICU admission for respirator weaning and delayed extubation; Pregnancy; Baseline hs-TnT level elevated above 65ng/L.