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Clinical Trials/NCT03625700
NCT03625700
Completed
Not Applicable

Supplementary Oxygen in Surgical and Medical Wards in the Capital Region of Denmark Evaluated by 30-day Mortality, a Retrospective Cohort Study

Hannibal Troensegaard1 site in 1 country11,196 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Oxygen gas
Conditions
Oxygen Toxicity
Sponsor
Hannibal Troensegaard
Enrollment
11196
Locations
1
Primary Endpoint
30- day mortality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the use and effects of supplementary oxygen in surgical and medical wards on patients admitted to a hospital in the capital region of Denmark. The population will be divided in to three groups according to their oxygenation status. The main outcome will be 30-day mortality, with secondary outcomes being Length of stay, 30-day admission to ICU, 30-day reoperations, 30-day readmission, and peak values within 30-days of C-reactive protein, S-Creatinine, Troponin.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hannibal Troensegaard
Responsible Party
Sponsor Investigator
Principal Investigator

Hannibal Troensegaard

Primary investigator

University Hospital Bispebjerg and Frederiksberg

Eligibility Criteria

Inclusion Criteria

  • Admission date between 1st of January 2014 to 29th of December 2014 on a hospital in the capital region of Denmark
  • Unique (first) admission in database for either:
  • Hip fracture requiring surgery
  • Chronic obstructive pulmonary disease in exacerbation
  • Acute mycardial infarction
  • Open abdominal surgery

Exclusion Criteria

  • No data on saturation within 48 hours after
  • Admission (Medical patients)
  • Discharge from the post anaesthesia care unit (Surgical patients)
  • No data on primary outcome (30-day mortality)

Arms & Interventions

Hypoxia

Patients without chronic obstructive pulmonary disease: blood oxygen saturation \<94 % irrespective of supplemental oxygen Patients with chronic obstructive pulmonary disease: blood oxygen saturation \<88% irrespective of supplemental oxygen

Intervention: Oxygen gas

Normoxia

Patients without chronic obstructive pulmonary disease: blood oxygen saturation 94-98% in combination with supplemental oxygen OR blood oxygen saturation ≥94% without supplemental oxygen. Patients with chronic obstructive pulmonary disease: blood oxygen saturation 88-92% in combination with supplemental oxygen OR blood oxygen saturation ≥88% without supplemental oxygen.

Intervention: Oxygen gas

Hyperoxia

Patients without chronic obstructive pulmonary disease: blood oxygen saturation \>98% in combination with supplemental oxygen Patients with chronic obstructive pulmonary disease: blood oxygen saturation \>92% in combination with supplemental oxygen

Intervention: Oxygen gas

Outcomes

Primary Outcomes

30- day mortality

Time Frame: 30 days

Will be reported as a fraction of positives within the exposure group population

Secondary Outcomes

  • 30- day readmission(30 days)
  • Organ markers in blood samples(30 days)
  • 30- day admission to ICU(30 days)
  • Length of stay(30 days)

Study Sites (1)

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