Oxygen ToxicitySOSAMNCT03625700
Supplementary Oxygen in Surgical and Medical Wards Evaluated by 30-day Mortality
An observational study of Oxygen Toxicity and Oxygen Deficiency, run by Hannibal Troensegaard at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygen Toxicity, Oxygen Deficiency
- What is being tested?
- Oxygen gas
- How many people
- 11,196 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2014to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Supplementary Oxygen in Surgical and Medical Wards in the Capital Region of Denmark Evaluated by 30-day Mortality, a Retrospective Cohort Study
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.
- Conditions
- Oxygen Toxicity, Oxygen Deficiency
- Being tested
- Oxygen gas
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen gasDrug
Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oxygen gas | |
| 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. Receives: Drug: Oxygen gas | |
| 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 Receives: Drug: Oxygen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
30- day mortality
Will be reported as a fraction of positives within the exposure group population
Measured: 30 days
Secondary outcomes (4)
Length of stay
Length of hospital stay in days
Measured: 30 days
Organ markers in blood samples
Highest value of C-reactive protein, Troponin and Creatinine within 30 days.
Measured: 30 days
30- day admission to ICU
Will be reported as a fraction of positives within the exposure group population.
Measured: 30 days
30- day readmission
will be reported as a fraction of positives within the exposure group population.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Jan 2014
- Primary completionAug 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannibal Troensegaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hannibal Troensegaard, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625700
- Sponsor's protocol ID
- OxyEWS2018
- Acronym
- SOSAM
- Status last verified
- Jan 2021
- First submitted
- 10 Jul 2018
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Oxygen in Surgical and Medical Wards in the Capital Region of Denmark Evaluated by 30-day Mortality, a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03625700
- Acronym / sponsor ID
- SOSAM / OxyEWS2018
- Conditions
- Oxygen Toxicity, Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,196 participants (actual)
- Lead sponsor
- Hannibal TroensegaardUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | – | Drug: Oxygen gasPatients 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 | – | Drug: Oxygen gasPatients 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 | – | Drug: Oxygen gasPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen gasSupplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission. | Drug | Hyperoxia, Hypoxia, Normoxia |
Primary outcome
30- day mortality
Time frame: 30 days
Will be reported as a fraction of positives within the exposure group population
4 secondary outcomes
Length of stay
Time frame: 30 days
Organ markers in blood samples
Time frame: 30 days
30- day admission to ICU
Time frame: 30 days
30- day readmission
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
Related trials for Oxygen Toxicity
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Oxygen Toxicity, Respiratory Failure
Recruiting
Oxygen Toxicity: Mechanisms in Humans
Oxygen Toxicity, Hypercapnia
Not yet recruiting
Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity
Oxygen Toxicity, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Toxicity and Oxygen Deficiency, run by Hannibal Troensegaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30- day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.