Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure

Обзор

Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide. Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated. Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.

Подробное описание

Patients admitted for a severe exacerbation of COPD that required NIV or invasive ventilation or high flow therapy will be screened for the trial once they reach clinical stability that allow weaning of NIV, invasive ventilation, or high flow therapy.

The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.

The inclusion visit will be performed no later than 30-days following discharge from the acute ward.

Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.

Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.

Вмешательства

• Устройство Non-invasive Ventilation (NIV)
  Patients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed.
• Устройство Continous Positive Airway Pressure (CPAP)
  Patients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP.

Первичные конечные точки

• Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death. [Срок оценки: 0-12 months from inclusion]

Вторичные конечные точки (12)

• Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing [Срок оценки: 0-12 months from inclusion]
• Quality of life of NIV over CPAP [Срок оценки: At month 3]
• Quality of life of NIV over CPAP [Срок оценки: At month 12]
• Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index). [Срок оценки: From Day 1 to Day 90]
• Quality of sleep of NIV over CPAP [Срок оценки: From Day 1 to Day 90]
• Quality of sleep of NIV over CPAP (Insomnia Severity Index). [Срок оценки: From Day 1 to Day 90]
• Quality of sleep of NIV over CPAP [Срок оценки: From Day 1 to Day 365]
• Quality of sleep of NIV over CPAP [Срок оценки: From Day 1 to Day 365]
• Quality of sleep of NIV over CPAP (Insomnia Severity Index). [Срок оценки: From Day 1 to Day 365]
• Quality of sleep of NIV over CPAP in centres that will perform overnight polysomnography [Срок оценки: From Day 1 to Day 365]
• Respiratory function benefit of NIV over CPAP [Срок оценки: From Day 1 to Day 365]
• Respiratory function benefit of NIV over CPAP [Срок оценки: At month 12]

Критерии участия

Критерии включения

• Age ≥ 18 and < 85 years
• Patient with a diagnosis of COPD according to GOLD guidelines
• Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa)
• Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
• Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index >=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
• Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
• Patient who has read and understood the information letter and signed the consent form

Критерии исключения

• Patient with NIV treatment
• Patients who decline any use of NIV or CPAP in the home setting
• Significant psychiatric disorder or dementia that would prevent adherence to study protocol
• Tobacco use <10 pack-year
• Expected survival <12 months due to any condition other than COPD.
• Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• Pregnant or breastfeeding women
• Patient already involved in an interventional research protocol that would impact 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

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement — Paris

Идентификаторы

NCT: NCT07047092 · NOCOCA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗