Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

Clinact

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease; COPD Exacerbation

Treatments: Device: home ventilators

Study type: Interventional

Funder types: Other

Identifiers

NCT03890224

2018-A01872-53 (Other Identifier)

R2M

Details and patient eligibility

About

The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.

Full description

By 2020, chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death in the world, especially in countries of middle to high income, like EU. Despite the improvements in survival by using acute non- invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of re-admission and further life-threatening events. Furthermore, in a recent study of 110 patients who had AHRF (RESCUE study, Struik, Thorax 2014), at one year after discharge 65% had another life-threatening event, and 49% had died. New recent data suggests that NIV at home can reduce re-admissions (HMV-LTOT, Murphy, JAMA 2017), but in a small proportion of patients, and with a high level of expertise. There is an urgent need to develop strategies to reduce the number and severity of exacerbations of COPD. With healthcare objectives and budget constraints, telemonitoring of COPD patients is an important challenge in most European countries. RESCUE2-Monitor is the next step. This European trial (currently, France, Spain and Portugal) will test the hypothesis that home NIV, with a highly adapted ventilatory strategy (hereafter referred to as 'TARGETED VENTILATION'), compared to no home NIV (only hospital NIV), to non-targeted home NIV or to rescue home NIV will reduce re-admission to hospital or death in COPD patients, is possible using e-medicine, and will reduce costs of health.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;
• 2. AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
• 3. 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).

Exclusion criteria

1. Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
2. Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;
3. BMI > 35 kg/m2;
4. Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
6. Cognitive impairment that would prevent informed consent into the trial
7. Pregnancy;
8. Tobacco use < 10 pack-year;
9. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge;
10. Unstable coronary artery syndrome;
11. Age <18 years;
12. Inability to comply with the protocol;
13. Expected survival<12 months due to any situation other than COPD disease;
14. Duration of ICU stay>10 days;
15. No affiliated to national health insurance;
16. Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Control group

No Intervention group

Description:

no home non-invasive ventilation (NIV), only hospital NIV

Non-targeted home NIV

Active Comparator group

Description:

Nocturnal home non-invasive ventilation (NIV)

Treatment:

Device: home ventilators

Targeted home NIV

Active Comparator group

Description:

Nocturnal home non-invasive ventilation (NIV) with high monitoring

Treatment:

Device: home ventilators

Rescue home NIV

Active Comparator group

Description:

home non-invasive ventilation (NIV) on demand

Treatment:

Device: home ventilators