Acute COPD Exacerbation MedDRA version: 21.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Medicinsk Oxygen "Strandmøllen"
Product Name: Medicinal Oxygen
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: OXYGEN
Concentration unit: % percent
Concentration type: equal
C
Sponsors
Mikkel Brabrand
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for the trial must comply with the following at randomization: 1. age 18 years or older 2. ability to give informed consent 3. previously diagnosed COPD (either confirmed diagnosis at prior hospital contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication)) 4. admitted with acute exacerbation (acute and worsened shortness of breath) of COPD 5. requiring oxygen treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 415 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 415
Exclusion criteria
Exclusion criteria: 1. Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes 2. Expected total length of stay in hospital < 12 hours 3. Planned transfer to another hospital within 12 hours 4. Unwilling to have repeated arterial blood gas analyses within the first 12 hours 5. Patients judged terminal by treating physician in the emergency department 6. Non-residents of the particular country 7. Expected impossible follow-up 8. Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG 9. Prior participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if titrated supplementary oxygen treatment to a low peripheral oxygen saturation initiated at arrival to the emergency department is superior to supplementary oxygen treatment titrated to a high peripheral oxygen saturation in reducing 30-day all-cause mortality in acutely admitted patients with COPD exacerbation.;Secondary Objective: To determine if supplementary oxygen titrated to a low peripheral oxygen saturation treatment initiated at arrival to the emergency department is superior to supplementary oxygen treatment titrated to a high peripheral oxygen saturation in acutely admitted patients with COPD exacerbation for, -reducing 7-day all-cause mortality -reducing need for non-invasive ventilation -reducing need for intubation -reducing intensive care admission -reducing over-all length of hospital stay -reducing the risk of respiratory acidosis ;Primary end point(s): The primary outcome is 30-day all-cause mortality extracted from the Danish national registries. ;Timepoint(s) of evaluation of this end point: 30 days after end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 7-day all-cause mortality extracted from the Danish national registries - non-invasive ventilation extracted from the hospital records - intubation extracted from the hospital records - intensive care admission extracted from the hospital records - over-all length of hospital stay calculated from the hospital records - respiratory acidosis (measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia) ;Timepoint(s) of evaluation of this end point: During admission and 7 days after end of trial | — |
Countries
Denmark
Contacts
Public ContactMikkel Brabrand
Research Unit in Emergency Medicine, SVS
Outcome results
None listed