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Recruiting NCT05196698

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

No phase Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Flow Oxygen Therapy, Long-term oxygen therapy.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other High Flow Oxygen Therapy
    HFOT will be delivered validated medical devices and established as follow: * Patient will be acclimatized to HFOT which will aim to achieve a flow of air of 30L/min at a temperature of 34°C using dedicated nasal canula. * Once patient acclimatized, oxygen will be entrained in the HFOT device at a flow that will aim to achieve a saturation \> 90%. An arterial blood gas will be performed with such oxygen delivery, flowrate and temperature to ensure a PaO2 ≥ 8kPa
  • Other Long-term oxygen therapy
    LTOT delivery will be performed according to French guidelines

Primary outcome measures

  • time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease [Time frame: 12 months]
  • time to death [Time frame: 12 months]
Secondary outcome measures (12)
  • Change from Baseline in Health-related Quality of Life [Time frame: 3 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 6 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 12 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 3 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 6 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 12 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 3 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 6 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 12 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 3 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 6 months]
  • Change from Baseline in Health-related Quality of Life [Time frame: 12 months]

Eligibility criteria

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-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 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • UHRouen — Rouen

Identifiers

NCT: NCT05196698 · 2019/0412/HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗