Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patient with a diagnosis of COPD defined by GOLD guidelines

• Admitted in hospital for AECOPD

• 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

• Patients affiliated or, beneficiary of a social security cover

• Patient who has read and understood the information letter and signed the consent form

• 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

• For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

Locations
Other Locations
France
UHRouen
RECRUITING
Rouen
Contact Information
Primary
Antoine CUVELIER, Pr
antoine.cuvelier@chu-rouen.fr
+33232889059
Backup
Armelle GUIDOTTI
armelle.guidotti@chu-rouen.fr
+33232888265
Time Frame
Start Date: 2022-08-26
Estimated Completion Date: 2026-08-26
Participants
Target number of participants: 406
Treatments
Experimental: High Flow Oxygen Therapy
Other: Long-Term Oxygen Therapy
Control arm
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov