NCT03625700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,196

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

6.6 years

First QC Date

July 10, 2018

Last Update Submit

January 10, 2021

Conditions

Oxygen ToxicityOxygen Deficiency

Outcome Measures

Primary Outcomes (1)

  • 30- day mortality

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

    30 days

Secondary Outcomes (4)

  • Length of stay

    30 days

  • Organ markers in blood samples

    30 days

  • 30- day admission to ICU

    30 days

  • 30- day readmission

    30 days

Study Arms (3)

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

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

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

Interventions

Oxygen gasDRUG

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

HyperoxiaHypoxiaNormoxia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg og Frederiksberg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Conditions

Hypoxia

Interventions

nitrox

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 10, 2018

Study Start

January 1, 2014

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

DK(1)