Trial intelligence / Profile preview

O2flow-COPD

NCT04223050Phase 4

Key facts

Status: Terminated
Start: Feb 2020
Primary completion: Aug 2024
Countries: 1
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Modality: GAS (Genetic analysis systems)

Drugs: oxygen gas
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 4, randomised, open-label trial of oxygen gas in chronic obstructive pulmonary disease (COPD) (2 arms), sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Primary endpoint: 30-day all-cause mortality. Started Feb 2020; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

High oxygen saturation
Peripheral oxygen saturation level >94%
Low oxygen saturation
Peripheral oxygen saturation level 88-92%

Who it enrols

Adult patients with a confirmed diagnosis of COPD admitted with an acute exacerbation requiring oxygen treatment. Excludes patients requiring immediate lifesaving treatment, expected hospital stay < 12 hours, planned transfer, terminal illness, or pregnant women.

Endpoints

Primary

30-day all-cause mortality30 days

Secondary

7-day all-cause mortality7 days
Need for non-invasive ventilation12 hours
Need for intubation12 hours
Intensive care admission1 day
Overall length of hospital stay10 days
Respiratory acidosis12 hours

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