Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease, Anesthesia
In brief
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.
Key facts
- Study ID
- NCT04808401
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 110
- Starts
- 2021-05-07
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2024-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Bern University Hospital, Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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