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

Oxygen Deficiency Clinical Trial

— SOSAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625700
• Other study ID #: OxyEWS2018
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2021
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11196
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency
• Oxygen Toxicity

Intervention

Drug:
• Oxygen gas
Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.

Locations

Country	Name	City	State
Denmark	Bispebjerg og Frederiksberg Hospital	København	NV

Sponsors (1)

Lead Sponsor	Collaborator
Hannibal Troensegaard

Country where clinical trial is conducted

Denmark, 

Outcome

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