Status:
TERMINATED
High-Flow in Hypercapnic Stable COPD Patients
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Icadom
Fisher and Paykel Healthcare
Conditions:
Adherence, Treatment
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Te...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous...
Eligibility Criteria
Inclusion
- Diagnosed with COPD (FEV1/FVC \< 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion.
- Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion.
- Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion.
- Able to understand, follow objectives and methods of protocol in French language.
- Patient affiliated to social security insurance or beneficiary of social health insurance.
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol.
Exclusion
- Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) \< 45%.
- Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.
- Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF.
- Patients who are unable or unwilling to give informed consent.
- Participating in another research study.
- Patient protected by the Law, under guardianship or curators.
- Pregnancy and nursing mothers
- Patient not covered by a health insurance.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04281316
Start Date
September 23 2020
End Date
December 16 2021
Last Update
May 24 2022
Active Locations (1)
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1
Grenoble Alpes University Hospital
Grenoble, France