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

NCT ID: NCT04808401

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2028-12-31

Brief Summary

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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

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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 samples for levels of myocardial biomarkers will be obtained at different perioperative time points (before anaesthesia induction, 2 hours after skin closure and 24 hours after the end of the surgery). The three myocardial biomarkers investigated are high-sensitive Troponin T (hsTnT), N-terminal (NT)-pro hormone BNP (NT-proBNP) and heart-type fatty acid binding protein (H-FABP). In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient.The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the patients are again randomly assigned to either the normoxaemic or the hyperoxic state for the remainder of the perioperative treatment until 2 hours after skin closure. Surgery will be performed as planned by the treating team. Differences in the perioperative levels of myocardial biomarkers at the different time points and their dynamics will be assessed. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Conditions

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Coronary Artery Disease Anesthesia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
TEE images will be coded and analysed in batches at a later date by a blinded reader

Study Groups

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Normoxaemia First + Hyperoxia Procedure

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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

Normoxaemia First + Normoxia Procedure

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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

Hyperoxia First + Hyperoxia Procedure

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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

Hyperoxia First + Normoxaemia Procedure

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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

Interventions

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Oxygen

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

Intervention Type DRUG

Other Intervention Names

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Medical gas

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominik P Guensch, MD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital, Inselspital

Jan-Oliver Friess, MD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital, Inselspital

Locations

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Bern University Hospital, Inselspital

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dominik P Guensch, MD

Role: CONTACT

Phone: +41 31 632 03 77

Email: [email protected]

Jan-Oliver Friess, MD

Role: CONTACT

Phone: +41 31 632 39 65

Email: [email protected]

Facility Contacts

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Dominik P Guensch, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32089047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31095334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37588173 (View on PubMed)

Other Identifiers

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2020_02560

Identifier Type: -

Identifier Source: org_study_id