NCT02562781

Brief Summary

Patients undergoing vascular surgery are at a significantly high risk of perioperative cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery. This could be because of co-morbidities that are common in this patient group. Additionally, smoking, which is common in this population, may be a contributing factor. Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing the risk for hypoxia and cell death. However, several studies published recently have questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve oxygen delivery, specifically in the neonatal period but possibly even following myocardial infarction. This could be explained by the fact that increasing inspired concentrations of oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow. Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS), and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death) in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not needed, it is routinely used in hospitals all over the world without a doctors prescription. This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 \> 90%).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

6.1 years

First QC Date

November 15, 2014

Last Update Submit

March 2, 2021

Conditions

Vascular Disease

Keywords

postoperative complicationspostoperative cognitive dysfunctionoxygen

Outcome Measures

Primary Outcomes (1)

  • Composite morbidity

    Major complications such as MACE, TIA/stroke/renal insufficiency/POCD etc

    0 - 1 month postoperatively

Secondary Outcomes (4)

  • Long term outcome (Major complications)

    1 month to 1 year postoperatively

  • Specific outcomes (Major adverse cardiac events (MACE))

    0 - 1 year postoperatively

  • Specific outcomes (TIA or stroke)

    0 - 1 year postoperatively

  • Specific outcomes (renal insufficiency including dialysis or renal failure)

    0 - 1 year postoperatively

Other Outcomes (1)

  • Complication (Re-operation or bleeding)

    0 - 30 days postoperatively

Study Arms (2)

Supplemental Oxygen

ACTIVE COMPARATOR

Inspired oxygen fraction \> 0.5 and SpO2 = 98-100%

Drug: OxygenOther: Air

Air or supplemental oxygen

EXPERIMENTAL

Air or lowest possible inspired concentration of oxygen to maintain SpO2 \> 90%

Drug: OxygenOther: Air

Interventions

OxygenDRUG

Oxygen in sufficient quantity to maintain SpO2 \> 98%

Also known as: Medical oxygen
Air or supplemental oxygenSupplemental Oxygen
AirOTHER

Supplemental Oxygen in sufficient quantity to maintain SpO2 \> 90%

Also known as: Medical Air
Air or supplemental oxygenSupplemental Oxygen

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients undergoing elective vascular surgery (peripheral or aortic surgery),
  • No language or cognitive disability
  • Written, informed consent

You may not qualify if:

  • Patients with COPD/other lung diseases that require preoperative oxygen therapy
  • Patients undergoing carotid artery surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Örebro, 701 85, Sweden

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Vascular DiseasesPostoperative ComplicationsPostoperative Cognitive Complications

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Anil Gupta, MD, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 15, 2014

First Posted

September 29, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

SE(2)