NCT04540276

Brief 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. 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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
8 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

August 31, 2020

Last Update Submit

February 3, 2021

Conditions

HyperoxiaMyocardial InfarctionMyocardial Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 30 days after surgery.

Secondary Outcomes (5)

  • All-cause mortality

    Within 30 days after surgery

  • Myocardial infarction

    Within 30 days after surgery

  • MINS

    Within 30 days after surgery

  • Rehospitalization for vascular reasons

    Within 30 days after surgery

  • Pneumonia

    Within 30 days after surgery

Other Outcomes (9)

  • Vascular mortality

    Within 30 days after surgery

  • Non-fatal cardiac arrest

    Within 30 days after surgery

  • Cardiac revascularization procedure

    Within 30 days after surgery

  • +6 more other outcomes

Interventions

Inspiratory oxygen fractionDRUG

Median inspiratory oxygen fraction during general anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients entered in the VISION database, undergoing noncardiac surgery in general anesthesia.

You may qualify if:

  • Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.

You may not qualify if:

  • Patients with unobtainable data on perioperative FiO2.
  • Patients with unobtainable data on postoperative troponin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Walter C. Mackenzie Health Sciences Centre

Edmonton, Canada

Location

Prince of Wales Hospital

Hong Kong, China

Location

Foundation CardioInfanil

Bogotá, Colombia

Location

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

Christian Medical College

Ludhiāna, India

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Inkosi Albert Luthuli Hospital

Durban, South Africa

Location

MeSH Terms

Conditions

HyperoxiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Christian S. Meyhoff, MD, PhD

    University hospital Bispebjerg Frederiksberg

    PRINCIPAL INVESTIGATOR

  • PJ Devereaux, MD, PhD

    Population Healt Research Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-student at Dept. of Anesthesia and Intensive Care

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

February 4, 2018

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

IN(1)DK(1)ZA(1)CA(1)CO(1)CN(1)MY(1)US(1)