Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04808401

Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-13

110

Participants Needed

1

Research Sites

395 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Scheduled for elective or non-emergent non-cardiac vascular surgery under general anesthesia with intubation
  • Have proven coronary artery disease and undergoing high- or intermediate-risk surgery according to European guidelines
  • Or have two or more risk factors for coronary artery disease and undergoing high- or intermediate-risk surgery according to European guidelines
Not Eligible

You will not qualify if you...

  • Acute coronary event within 30 days before surgery
  • Acute congestive heart failure
  • Hemodynamic instability before anesthesia induction requiring vasopressor or inotrope infusion
  • Atrial fibrillation or other severe arrhythmia
  • Severe pulmonary disease needing oxygen therapy or stage 4 COPD, severe carbon monoxide diffusion impairment, or severe pulmonary hypertension
  • Preoperative oxygen saturation below 90% on room air
  • Increased risk of oxygen toxicity (e.g., recent chemotherapy, bleomycin treatment, airway laser surgery)
  • Scheduled thoracic cavity surgery
  • ICU admission for respirator weaning and delayed extubation
  • Pre-existing surgical site infection
  • Active systemic inflammatory response syndrome or sepsis
  • Pregnancy
  • Emergency surgery planned within less than 12 hours
  • Ambulatory surgery
  • Baseline high-sensitive Troponin T level above 65 ng/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bern University Hospital, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

D

Dominik P Guensch, MD

CONTACT

J

Jan-Oliver Friess, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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