Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Last updated: May 23, 2023
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

High Flow Oxygen Therapy

Long-term oxygen therapy

Clinical Study ID

NCT05196698
2019/0412/HP
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  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-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
  1. Patients affiliated or, beneficiary of a social security cover
  2. Patient who has read and understood the information letter and signed the consent form
  3. 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
  4. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for atleast 12 months before the inclusion visit)

Exclusion

Exclusion Criteria:

  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 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
  1. is >3, an Apnea-link recording will be performed. If AHI>30/h, patient will beexcluded.
  1. BMI > 35 kg/m2
  2. Patient admitted for an acute COVID-19 infection
  3. Hypercapnic respiratory failure justifying NIV defined as
  4. An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months
  5. Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remainedhypercapnic between 2- and 4-weeks following discharge
  6. Pregnancy (blood pregnancy test positive) or lactation ongoing
  7. Significant psychiatric disorder or dementia that would prevent adherence to studyprotocol
  8. Tobacco use < 10 pack-year
  9. Expected survival < 12 months due to any situation other than COPD disease
  10. Refusal of high-flow oxygen therapy
  11. Person deprived of liberty by administrative or judicial decision or placed underjudicial protection (guardianship or supervision)
  12. 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,
    France

    Active - Recruiting

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