HyperoxiaNCT04540276
Intraoperative Hyperoxia and MINS
An observational study of Hyperoxia and Myocardial Infarction, run by University Hospital Bispebjerg and Frederiksberg at 8 sites in 8 countries.
Trial summary
Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia, Myocardial Infarction, Myocardial Injury
- What is being tested?
- Inspiratory oxygen fraction
- How many people
- 7,700 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 4 Feb 2018to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients entered in the VISION database, undergoing noncardiac surgery in general anesthesia.
Who may be able to join
- Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.
Who cannot join
- Patients with unobtainable data on perioperative FiO2.
- Patients with unobtainable data on postoperative troponin.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: Intraoperative Hyperoxia and MINS: A Post Hoc Analysis From the VISION Study Database
Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. In this post hoc substudy of the VISION cohort, we plan to assess the association between perioperative inspired oxygen fraction (FiO2) and myocardial injury after non-cardiac surgery (MINS).
Read the detailed description
Patients will be divided into five groups of median intraoperative FiO2 (quintiles), in which baseline characteristics and outcomes will be illustrated.
The odds ratio (OR) for the primary and secondary outcomes will be calculated in a logistic regression analysis with median FiO2 (continuous variable) as independent variable.
Analyses are performed with multiple logistic regression with adjustment for the following potentially confounding variables:
Age ≥75 years. Male sex. Current atrial fibrillation. History of diabetes. History of congestive heart failure. History of coronary artery disease. History of recent (i.e., < 6 months) high-risk coronary artery disease. History of stroke. History of peripheral vascular disease. History of hypertension. Preoperative eGFR (<30 vs. 30-44 vs. 45-59 vs. ≥60 mL/min/1.73m2). Low-risk surgery. Duration of surgery.
- Conditions
- Hyperoxia, Myocardial Infarction, Myocardial Injury
- Being tested
- Inspiratory oxygen fraction
- Medical subject headings
- Hyperoxia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory oxygen fractionDrug
Median inspiratory oxygen fraction during general anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury after non-cardiac surgery (MINS)
Number of participants with MINS in the specified oxygen groups. MINS is defined as either ischemic troponin elevation or myocardial infarction after non-cardiac surgery.
Measured: Within 30 days after surgery.
Secondary outcomes (5)
All-cause mortality
Number of deaths within 30 days after surgery
Measured: Within 30 days after surgery
Myocardial infarction
Number of participants with myocardial infarction within 30 days after surgery
Measured: Within 30 days after surgery
MINS
Number of participants with MINS not fulfilling the fourth universal definition of myocardial infarction
Measured: Within 30 days after surgery
Rehospitalization for vascular reasons
Number of participants rehospitalized for vascular reasons within 30 days after surgery
Measured: Within 30 days after surgery
Pneumonia
Number of participants with pneumonia within 30 days after surgery
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start4 Feb 2018
- Primary completion1 Oct 2020
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Principal investigator, Sofie Pedersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian S. Meyhoff, MD, PhD, Principal investigator, University hospital Bispebjerg FrederiksbergPJ Devereaux, MD, PhD, Study chair, Population Healt Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540276
- Sponsor's protocol ID
- Hyperoxia and MINS
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hyperoxia and MINS: A Post Hoc Analysis From the VISION Study Database
- ClinicalTrials.gov ID
- NCT04540276
- Acronym / sponsor ID
- Hyperoxia and MINS
- Conditions
- Hyperoxia, Myocardial Infarction, Myocardial Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,700 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 4 Feb 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. In this post hoc substudy of the VISION cohort, we plan to assess the association between perioperative inspired oxygen fraction (FiO2) and myocardial injury after non-cardiac surgery (MINS).
Detailed description
Patients will be divided into five groups of median intraoperative FiO2 (quintiles), in which baseline characteristics and outcomes will be illustrated.
The odds ratio (OR) for the primary and secondary outcomes will be calculated in a logistic regression analysis with median FiO2 (continuous variable) as independent variable.
Analyses are performed with multiple logistic regression with adjustment for the following potentially confounding variables:
Age ≥75 years. Male sex. Current atrial fibrillation. History of diabetes. History of congestive heart failure. History of coronary artery disease. History of recent (i.e., < 6 months) high-risk coronary artery disease. History of stroke. History of peripheral vascular disease. History of hypertension. Preoperative eGFR (<30 vs. 30-44 vs. 45-59 vs. ≥60 mL/min/1.73m2). Low-risk surgery. Duration of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients entered in the VISION database, undergoing noncardiac surgery in general anesthesia.
Key inclusion criteria (1 listed)
- Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.
Key exclusion criteria (2 listed)
- Patients with unobtainable data on perioperative FiO2.
- Patients with unobtainable data on postoperative troponin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory oxygen fractionMedian inspiratory oxygen fraction during general anesthesia | Drug | – |
Primary outcome
Myocardial injury after non-cardiac surgery (MINS)
Time frame: Within 30 days after surgery.
Number of participants with MINS in the specified oxygen groups. MINS is defined as either ischemic troponin elevation or myocardial infarction after non-cardiac surgery.
5 secondary outcomes
All-cause mortality
Time frame: Within 30 days after surgery
Myocardial infarction
Time frame: Within 30 days after surgery
MINS
Time frame: Within 30 days after surgery
Rehospitalization for vascular reasons
Time frame: Within 30 days after surgery
Pneumonia
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Related trials for Hyperoxia
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Acute Ischemic Stroke
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Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
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Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S. Meyhoff, MD, PhD principal investigator
University hospital Bispebjerg Frederiksberg
PJ Devereaux, MD, PhD study chair
Population Healt Research Institute
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperoxia and Myocardial Infarction, run by University Hospital Bispebjerg and Frederiksberg at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, China, Colombia, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury after non-cardiac surgery (MINS) (time frame: Within 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.