Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elect… (NCT04808401) | Clinical Trial Compass
RecruitingNot Applicable
Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
Switzerland110 participantsStarted 2021-05-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…