Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

Official title

Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support

Overview

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.

Detailed 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.

Interventions

• Device home ventilators
  The 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked.

Primary outcome measures

• admission-free survival [Time frame: 0-36 months]

Secondary outcome measures (12)

• Overall survival [Time frame: 0-36 months]
• Frequency of exacerbations requiring hospitalization [Time frame: 12 months]
• Frequency of exacerbations resulting in physician directed treatment [Time frame: 12 months]
• Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide [Time frame: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months]
• Assessment of Exacerbation based on changes in arterial partial pressure of oxygen [Time frame: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months]
• Assessment of Quality of life with St George's respiratory questionnaire [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of life with Severe Respiratory Insufficiency Questionnaire [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of life with SF-36 [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of life with the 5-level EQ-5D version [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of life with the Charlson Comorbidity Index [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of life with the COPD Assessment Test (CAT) [Time frame: 0,1, 3, 6, 24 and 36 months]
• Assessment of Quality of sleep with Pittsburgh Sleep Quality Index [Time frame: 0,1, 3, 6, 24 and 36 months]

Eligibility criteria

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

• Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
• 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;
• BMI > 35 kg/m2;
• Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
• Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
• Cognitive impairment that would prevent informed consent into the trial
• Pregnancy;
• Tobacco use < 10 pack-year;
• Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge;
• Unstable coronary artery syndrome;
• Age <18 years;
• Inability to comply with the protocol;
• Expected survival<12 months due to any situation other than COPD disease;
• Duration of ICU stay>10 days;
• No affiliated to national health insurance;
• Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.

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

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Groupe Hospitalier Pitié Salpêtrière-Charles Foix — Paris

Publications

• Rescue2-monitor group. Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease. Trials. 2020 Oct 22;21(1):877. doi: 10.11 PMID 33092618

Identifiers

NCT: NCT03890224 · R2M · 2018-A01872-53

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗