Status:
RECRUITING
Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Coronary Artery Disease
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Up to 110 patients with either proven coronary artery disease (CAD) or two or more risk factors for CAD undergoing elective or non-emergent non-cardiac vascular surgery will be recruited. Three blood ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04808401
Start Date
May 7 2021
End Date
December 1 2028
Last Update
December 13 2024
Active Locations (1)
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1
Bern University Hospital, Inselspital
Bern, Switzerland, 3010