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

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

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.

Study Overview

• Status: Completed
• Conditions: Oxygen Deficiency; Oxygen Toxicity
• Intervention / Treatment: Drug: Oxygen gas

• Study Type: Observational
• Enrollment (Actual): 11196

Contacts and Locations

Study Locations

• Denmark
  • NV
    • København, NV, Denmark, 2400
      • Bispebjerg Og Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study is made up of four main population groups, each group having their specific vulnerabilities, thus making the main outcome (30-day mortality) more likely to occur than in the background population.

The four groups are:

1. Patients undergoing laparotomy (open abdominal surgery)
2. Patients undergoing orthopedic surgery due to hip fracture
3. Patients admitted to hospital due to chronic obstructive pulmonary disease in exacerbation
4. Patients admitted to hospital with acute mycardial infarction

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Oxygen gas; Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.
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.	Drug: Oxygen gas; Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.
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	Drug: Oxygen gas; Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30- day mortality	Will be reported as a fraction of positives within the exposure group population	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hannibal Troensegaard

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): August 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: OxyEWS2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No