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

Hannibal Troensegaard

Status: Completed

Conditions: Oxygen Deficiency; Oxygen Toxicity

Treatments: Drug: Oxygen gas

Study type: Observational

Funder types: Other

Identifiers

NCT03625700

OxyEWS2018

Details and patient eligibility

About

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.

Enrollment: 11,196 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

11,196 participants in 3 patient groups

Hypoxia

Description:

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

Treatment:

Drug: Oxygen gas

Normoxia

Description:

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.

Treatment:

Drug: Oxygen gas

Hyperoxia

Description:

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

Treatment:

Drug: Oxygen gas