Status:
RECRUITING
Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
Lead Sponsor:
University Hospital, Rouen
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Age \<18 or \> 85 years
- Patient treated with chronic NIV with ongoing treatment
- 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.
- BMI \> 35 kg/m2
- Patient admitted for an acute COVID-19 infection
- Hypercapnic respiratory failure justifying NIV defined as
- An Arterial Blood Gas (ABG) PaCO2 \> 7 kPa in stable condition within 6 months
- Patients with ABG PaCO2 \> 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
- Pregnancy (blood pregnancy test positive) or lactation ongoing
- Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- Tobacco use \< 10 pack-year
- Expected survival \< 12 months due to any situation other than COPD disease
- Refusal of high-flow oxygen therapy
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Patients already involved in a research protocol that would impact with the outcome measured in the current protocol
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2026
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT05196698
Start Date
August 26 2022
End Date
August 26 2026
Last Update
May 25 2023
Active Locations (1)
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1
UHRouen
Rouen, France