Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mikkel Brabrand
• Collaborator: Region of Southern Denmark

Criteria

Inclusion Criteria:

• age 18 years or older

• ability to give informed consent

• 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))

• admitted with acute exacerbation (acute and worsened shortness of breath) of COPD

• requiring oxygen treatment

Exclusion Criteria:

• Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes

• Expected total length of stay in hospital < 12 hours

• Planned transfer to another hospital within 12 hours

• Unwilling to have repeated arterial blood gas analyses within the first 12 hours

• Patients judged terminal by treating physician in the emergency department

• Non-residents of the particular country

• Expected impossible follow-up

• Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG

• Prior participation in the study