Back to resultsInfluence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery (Promise-O2)
Primary Purpose
Coronary Artery Disease, Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial biomarkers, Normoxaemia, Anaesthesia
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
Sites / Locations
- Bern University Hospital, InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Normoxaemia First + Hyperoxia Procedure
Normoxaemia First + Normoxia Procedure
Hyperoxia First + Hyperoxia Procedure
Hyperoxia First + Normoxaemia Procedure
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Difference in hsTnT from preoperative baseline
ng/L
Secondary Outcome Measures
Incidence of myocardial injury in non-cardiac surgery (MINS)
MINS is defined as an absolute change of hsTnT levels of at least 5ng/L from preoperative baseline or an hs-TnT level of at least 65ng/L
Difference in high sensitive TnT from preoperative baseline
ng/L
Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline
pg/ml
Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline
pg/ml
Difference in myocardial time to peak strain between oxygen levels
Milliseconds (ms)
Difference in myocardial strain rate between oxygen levels
Change in strain over time (/second)
Difference in myocardial strain rate ratio between oxygen levels
Change in E/A ratio
Difference in myocardial displacement between oxygen levels
Millimeters (mm)
Difference in myocardial time to peak displacement between oxygen levels
Milliseconds (ms)
Difference in myocardial velocities between oxygen levels
Change in displacement over time (millimeters/second)
Difference in myocardial velocity ratio between oxygen levels
Change in E/A ratio
Difference in peak twist
Degrees (°)
Difference in peak torsion
Degrees/centimeter (°/cm)
Difference in ejection fraction (EF)
Percent (%)
Difference in chamber volumes
Millilitres (ml)
Full Information
NCT ID
NCT04808401
First Posted
March 15, 2021
Last Updated
November 7, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT04808401
Brief Title
Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
Acronym
Promise-O2
Official Title
Influence of Different Inspired Oxygen Fractions on Perioperative Myocardial Biomarkers, Myocardial Strain and Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery: A Prospective Randomized Open-label Single Centre Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anesthesia
Keywords
Coronary Artery Disease, Transesophageal Echocardiography (TEE), Hyperoxia, Strain, Myocardial biomarkers, Normoxaemia, Anaesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
TEE images will be coded and analysed in batches at a later date by a blinded reader
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normoxaemia First + Hyperoxia Procedure
Arm Type
Experimental
Arm Description
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.
Arm Title
Normoxaemia First + Normoxia Procedure
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyperoxia First + Hyperoxia Procedure
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyperoxia First + Normoxaemia Procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
Medical gas
Intervention Description
Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
Primary Outcome Measure Information:
Title
Difference in hsTnT from preoperative baseline
Description
ng/L
Time Frame
at 24 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of myocardial injury in non-cardiac surgery (MINS)
Description
MINS is defined as an absolute change of hsTnT levels of at least 5ng/L from preoperative baseline or an hs-TnT level of at least 65ng/L
Time Frame
at 24 hours after surgery
Title
Difference in high sensitive TnT from preoperative baseline
Description
ng/L
Time Frame
at 2 hours after surgery
Title
Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline
Description
pg/ml
Time Frame
at 2 hours and 24 hours after surgery
Title
Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline
Description
pg/ml
Time Frame
at 2 hours and 24 hours after surgery
Title
Difference in myocardial time to peak strain between oxygen levels
Description
Milliseconds (ms)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial strain rate between oxygen levels
Description
Change in strain over time (/second)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial strain rate ratio between oxygen levels
Description
Change in E/A ratio
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial displacement between oxygen levels
Description
Millimeters (mm)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial time to peak displacement between oxygen levels
Description
Milliseconds (ms)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial velocities between oxygen levels
Description
Change in displacement over time (millimeters/second)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in myocardial velocity ratio between oxygen levels
Description
Change in E/A ratio
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in peak twist
Description
Degrees (°)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in peak torsion
Description
Degrees/centimeter (°/cm)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in ejection fraction (EF)
Description
Percent (%)
Time Frame
Through study completion, within 1hour post-induction
Title
Difference in chamber volumes
Description
Millilitres (ml)
Time Frame
Through study completion, within 1hour post-induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik P Guensch, MD
Phone
+41 31 632 03 77
Email
dominik.guensch@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Jan-Oliver Friess, MD
Phone
+41 31 632 39 65
Email
jan-oliver.friess@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik P Guensch, MD
Organizational Affiliation
Bern University Hospital, Inselspital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan-Oliver Friess, MD
Organizational Affiliation
Bern University Hospital, Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bern University Hospital, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik P Guensch, MD
Phone
+41 31 632 03 77
Email
dominik.guensch@insel.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32089047
Citation
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.
Results Reference
background
PubMed Identifier
31095334
Citation
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.
Results Reference
background
Learn more about this trial
Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery
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