Using home high flow oxygen to reduce severe COPD flare-ups

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of home high flow oxygen therapy compared to standard oxygen therapy in reducing severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) following hospital admission. Patients diagnosed with COPD and experiencing severe respiratory impairment will be enrolled after their hospital stay. The study aims to determine if high flow oxygen can lead to better outcomes in terms of exacerbation rates and overall patient health.

Why it matters

Who can join: the full rules

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-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
4. Patients affiliated or, beneficiary of a social security cover
5. Patient who has read and understood the information letter and signed the consent form
6. 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
7. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

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 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.
4. BMI \> 35 kg/m2
5. Patient admitted for an acute COVID-19 infection
6. Hypercapnic respiratory failure justifying NIV defined as

   1. An Arterial Blood Gas (ABG) PaCO2 \> 7 kPa in stable condition within 6 months
   2. Patients with ABG PaCO2 \> 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
7. Pregnancy (blood pregnancy test positive) or lactation ongoing
8. Significant psychiatric disorder or dementia that would prevent adherence to study protocol
9. Tobacco use \< 10 pack-year
10. Expected survival \< 12 months due to any situation other than COPD disease
11. Refusal of high-flow oxygen therapy
12. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
13. Patients already involved in a research protocol that would impact with the outcome measured in the current protocol

Where it's running

• UHRouen
  Rouen, France Recruiting

Study contacts

• Principal investigator: Antoine CUVELIER, Pr — University Hospital, Rouen
• Study coordinator: Antoine CUVELIER, Pr
• Email: antoine.cuvelier@chu-rouen.fr
• Phone: +33232889059

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.