Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

Last updated: June 17, 2024
Sponsor: Clinact
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

home ventilators

Clinical Study ID

NCT03890224
R2M
2018-A01872-53
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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. obesityhypoventilation and chest wall disease, however these patients will be included ifthe "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if thepredominant 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 ofmorphine/day);

  5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (Frenchcriteria);

  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 fordrug 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) forpatients over the age of majority.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: home ventilators
Phase:
Study Start date:
July 04, 2019
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Groupe Hospitalier Pitié Salpêtrière-Charles Foix

    Paris, Ile-de-France 75651
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.