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Completed

NCT Number: NCT03625700

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

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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Key information

Conditions

Oxygen Toxicity Hypoxia Oxygen Deficiency Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg og Frederiksberg Hospital

Copenhagen, NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxygen gas

Drug

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

Primary outcomes

  1. 30- day mortality

    Time frame: 30 days

    Will be reported as a fraction of positives within the exposure group population

Secondary outcomes

  1. Length of stay

    Time frame: 30 days

    Length of hospital stay in days

  2. Organ markers in blood samples

    Time frame: 30 days

    Highest value of C-reactive protein, Troponin and Creatinine within 30 days.

  3. 30- day admission to ICU

    Time frame: 30 days

    Will be reported as a fraction of positives within the exposure group population.

  4. 30- day readmission

    Time frame: 30 days

    will be reported as a fraction of positives within the exposure group population.

Sponsors and collaborators

Lead sponsor

Hannibal Troensegaard

Other

Registry information

Official study title

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

Acronym: SOSAM

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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