NCT05196698 Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
| NCT ID | NCT05196698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 406 participants |
| Start Date | 2022-08-26 |
| Primary Completion | 2026-08-26 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The objective of the study is to evaluate the efficacy of home High Flow Oxygen for the reduction of severe exacerbation following admission for a severe exacerbation of COPD or death against standard oxygen therapy.
Eligibility Criteria
Inclusion Criteria: 1. Patient with a diagnosis of COPD defined by GOLD guidelines 2. Admitted in hospital for AECOPD 3. With severe respiratory impairment defined by one of the following criteria (long-term oxygen therapy (LTOT) criteria): * Previously established on long-term oxygen therapy according to the following criteria: PaO2 \< 7.3kPa or \<8kPa with polycythemia, pulmonary hypertension or right heart failure on room air in stable condition Or * PaO2 \< 7.3kPa or \<8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index admission 4. Patients affiliated or, beneficiary of a social security cover 5. Patient who has read and understood the information letter and signed the consent form 6. For woman of childbearing potential, use of an effective contraception (oestro-progestatives or intra-uterine device or tubal ligation) since at least 1 month and an blood pregnancy test by β-HCG negative at the screening vis