Last updated: May 23, 2023
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
High Flow Oxygen Therapy
Long-term oxygen therapy
Clinical Study ID
NCT05196698
2019/0412/HP
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-termoxygen therapy (LTOT) criteria):
- Previously established on long-term oxygen therapy according to the followingcriteria: PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension orright heart failure on room air in stable condition Or
- PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heartfailure 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 1month and an blood pregnancy test by β-HCG negative at the screening visit, during theduration of the study
- For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for atleast 12 months before the inclusion visit)
Exclusion
Exclusion Criteria:
- Age <18 or > 85 years
- Patient treated with chronic NIV with ongoing treatment
- Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis ofOSA will be over-ruled in patient that had a previous overnight polygraphy. Forpatients who never had an overnight polygraphy, screening for OSA will be made usingthe STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix
- is >3, an Apnea-link recording will be performed. If AHI>30/h, patient will beexcluded.
- 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 remainedhypercapnic 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 studyprotocol
- 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 underjudicial protection (guardianship or supervision)
- Patients already involved in a research protocol that would impact with the outcomemeasured in the current protocol
Study Design
Total Participants: 406
Treatment Group(s): 2
Primary Treatment: High Flow Oxygen Therapy
Phase:
Study Start date:
August 26, 2022
Estimated Completion Date:
August 26, 2026
Connect with a study center
UHRouen
Rouen,
FranceActive - Recruiting
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