NCT04808401 Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
| NCT ID | NCT04808401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-05-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2021-05-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Dominik P Guensch, MD
PRINCIPAL INVESTIGATOR
Bern University Hospital, Inselspital
Frequently Asked Questions
Who can join the NCT04808401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04808401 currently recruiting?
Yes, NCT04808401 is actively recruiting participants. Contact the research team at dominik.guensch@insel.ch for enrollment information.
Where is the NCT04808401 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04808401 clinical trial?
NCT04808401 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Dominik P Guensch, MD at Bern University Hospital, Inselspital. The trial plans to enroll 110 participants.