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

NCT04808401 | Recruiting

• 1 other identifier: 2020_02560
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Anesthesia

Keywords

Coronary Artery Disease; Transesophageal Echocardiography (TEE); Hyperoxia; Strain; Myocardial biomarkers; Normoxaemia; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Difference in hsTnT from preoperative baseline

  ng/L

  at 24 hours after surgery

Secondary Outcomes (15)

• Incidence of myocardial injury in non-cardiac surgery (MINS)

  at 24 hours after surgery

• Difference in high sensitive TnT from preoperative baseline

  at 2 hours after surgery

• Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline

  at 2 hours and 24 hours after surgery

• Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline

  at 2 hours and 24 hours after surgery

• Difference in myocardial time to peak strain between oxygen levels

  Through study completion, within 1hour post-induction

Study Arms (4)

Normoxaemia First + Hyperoxia Procedure

EXPERIMENTAL

Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second. After the image acquisition patients receive hyperoxic concentrations.

Drug: Oxygen

Normoxaemia First + Normoxia Procedure

EXPERIMENTAL

Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second. After the image acquisition patients receive normoxic concentrations.

Drug: Oxygen

Hyperoxia First + Hyperoxia Procedure

EXPERIMENTAL

Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second. After the image acquisition patients receive hyperoxic concentrations.

Drug: Oxygen

Hyperoxia First + Normoxaemia Procedure

EXPERIMENTAL

Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second. After the image acquisition patients receive normoxic concentrations.

Drug: Oxygen

Interventions

Oxygen DRUG

Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.

Also known as: Medical gas

Hyperoxia First + Hyperoxia Procedure; Hyperoxia First + Normoxaemia Procedure; Normoxaemia First + Hyperoxia Procedure; Normoxaemia First + Normoxia Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (3)

• Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.

  PMID: 32089047 BACKGROUND

• Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301.

  PMID: 31095334 BACKGROUND

• Friess JO, Mikasi J, Baumann R, Ranjan R, Fischer K, Levis A, Terbeck S, Hirschi T, Gerber D, Erdoes G, Schoenhoff FS, Carrel TP, Madhkour R, Eberle B, Guensch DP. Hyperoxia-induced deterioration of diastolic function in anaesthetised patients with coronary artery disease - Randomised crossover trial. BJA Open. 2023 Apr 27;6:100135. doi: 10.1016/j.bjao.2023.100135. eCollection 2023 Jun.

  PMID: 37588173 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Hyperoxia; Sprains and Strains

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Dominik P Guensch, MD

  Bern University Hospital, Inselspital

  PRINCIPAL INVESTIGATOR

• Jan-Oliver Friess, MD

  Bern University Hospital, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik P Guensch, MD

CONTACT

+41 31 632 03 77; dominik.guensch@insel.ch

Jan-Oliver Friess, MD

CONTACT

+41 31 632 39 65; jan-oliver.friess@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: TEE images will be coded and analysed in batches at a later date by a blinded reader
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients start with a crossover design undergoing both TEE images at normoxia and hyperoxia in random order and then are randomized a second time to receive either normoxia or hyperoxia for the remaining procedure in a parallel design.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 22, 2021
• Study Start: May 7, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)