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

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease Exacerbation; Obstructive Sleep Apnea Exacerbation

Treatments: Device: Continous Positive Airway Pressure (CPAP); Device: Non-invasive Ventilation (NIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT07047092

NOCOCA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 386 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 and < 85 years
2. Patient with a diagnosis of COPD according to GOLD guidelines
3. 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)
4. Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
5. 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.
6. Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
7. Patient who has read and understood the information letter and signed the consent form

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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386 participants in 2 patient groups

Non-invasive Ventilation (NIV)

Experimental group

Description:

Patients randomised to the intervention arm will be established on NIV before discharge to home.

Treatment:

Device: Non-invasive Ventilation (NIV)

Continuous Positive Airway Pressure (CPAP)

Active Comparator group

Description:

Patients randomised to the control arm will be established on CPAP before discharge to home.

Treatment:

Device: Continous Positive Airway Pressure (CPAP)