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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
| |
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen gas | Drug | Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30- day mortality | Will be reported as a fraction of positives within the exposure group population | 30 days |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg og Frederiksberg Hospital | Copenhagen | NV | 2400 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2018 | Jul 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C041364 | nitrox |
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| 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 |