RecruitingChronic Obstructive Pulmonary Disease
Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
Eligible age
18–85 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: University Hospital, Rouen
You may qualify if…
- ✓ 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 visit, during the duration of the study
You may not qualify if…
- ✕ 1. Age \<18 or \> 85 years
- ✕ 2. Patient treated with chronic NIV with ongoing treatment
- ✕ 3. Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis of OSA will be over-ruled in patient that had a previous overnight polygraphy. For patients who never had an overnight polygraphy, screening for OSA will be made using the STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix 1) is \>3, an Apnea-link recording will be performed. If AHI\>30/h, patient will be excluded.
- ✕ 4. BMI \> 35 kg/m2
- ✕ 5. Patient admitted for an acute COVID-19 infection
- ✕ 6. Hypercapnic respiratory failure justifying NIV defined as
- ✕ 1. An Arterial Blood Gas (ABG) PaCO2 \> 7 kPa in stable condition within 6 months
- ✕ 2. Patients with ABG PaCO2 \> 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
Source: ClinicalTrials.gov · NCT05196698 · last updated 2026-02-06