Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Обзор

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.

Вмешательства

• Другое 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
• Другое Long-term oxygen therapy
  LTOT delivery will be performed according to French guidelines

Первичные конечные точки

• time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease [Срок оценки: 12 months]
• time to death [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Change from Baseline in Health-related Quality of Life [Срок оценки: 3 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 6 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 12 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 3 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 6 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 12 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 3 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 6 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 12 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 3 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 6 months]
• Change from Baseline in Health-related Quality of Life [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• UHRouen — Rouen

Идентификаторы

NCT: NCT05196698 · 2019/0412/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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