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

NCT ID: NCT03625700

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oxygen Toxicity Oxygen Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Oxygen gas

Intervention Type DRUG

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.

Oxygen gas

Intervention Type DRUG

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

Oxygen gas

Intervention Type DRUG

Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.

Interventions

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Oxygen gas

Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannibal Troensegaard

OTHER

Sponsor Role lead

Responsible Party

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Hannibal Troensegaard

Primary investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bispebjerg og Frederiksberg Hospital

Copenhagen, NV, Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OxyEWS2018

Identifier Type: -

Identifier Source: org_study_id

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