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

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ClinicalTrials.gov Identifier: NCT03625700
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hannibal Troensegaard, University Hospital Bispebjerg and Frederiksberg

Brief 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.

Condition or disease Intervention/treatment
Oxygen Toxicity Oxygen Deficiency Drug: Oxygen gas

Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Supplementary Oxygen in Surgical and Medical Wards in the Capital Region of Denmark Evaluated by 30-day Mortality, a Retrospective Cohort Study
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
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

Drug: Oxygen gas
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.

Drug: Oxygen gas
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

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




Primary Outcome Measures :
  1. 30- day mortality [ Time Frame: 30 days ]
    Will be reported as a fraction of positives within the exposure group population


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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:

  1. Patients undergoing laparotomy (open abdominal surgery)
  2. Patients undergoing orthopedic surgery due to hip fracture
  3. Patients admitted to hospital due to chronic obstructive pulmonary disease in exacerbation
  4. Patients admitted to hospital with acute mycardial infarction
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625700


Contacts
Contact: Hannibal Troensegaard +45 36636239 hannibal.troensegaard@regionh.dk
Contact: Christian Meyhoff, P.hd, MD christian.sahlholt.meyhoff@regionh.dk

Locations
Denmark
Bispebjerg og Frederiksberg Hospital Recruiting
København, NV, Denmark, 2400
Contact: Hannibal Troensegaard       hannibal.troensegaard@regionh.dk   
Sponsors and Collaborators
Hannibal Troensegaard
  Study Documents (Full-Text)

Documents provided by Hannibal Troensegaard, University Hospital Bispebjerg and Frederiksberg:

Responsible Party: Hannibal Troensegaard, Primary investigator, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT03625700     History of Changes
Other Study ID Numbers: OxyEWS2018
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms