Supplementary Oxygen in Surgical and Medical Wards Evaluated by 30-day Mortality

Completed

• Conditions: Oxygen Toxicity; Oxygen Deficiency
• Interventions: Drug: Oxygen gas

• Registration Number: NCT03625700
• Lead Sponsor: Hannibal Troensegaard

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-10
• Primary Completion: 2020-08
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-10
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11196

Inclusion Criteria

• Admission date between 1st of January 2014 to 29th of December 2014 on a hospital in the capital region of Denmark
• Age ≥18
• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperoxia	Oxygen gas	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
Normoxia	Oxygen gas	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.
Hypoxia	Oxygen gas	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

Primary Outcome Measures

Name	Time	Method
30- day mortality	30 days	Will be reported as a fraction of positives within the exposure group population

Secondary Outcome Measures

Name	Time	Method
30- day admission to ICU	30 days	Will be reported as a fraction of positives within the exposure group population.
30- day readmission	30 days	will be reported as a fraction of positives within the exposure group population.
Organ markers in blood samples	30 days	Highest value of C-reactive protein, Troponin and Creatinine within 30 days.
Length of stay	30 days	Length of hospital stay in days

Trial Locations

Locations (1)

Bispebjerg og Frederiksberg Hospital; 🇩🇰 København, NV, Denmark