Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT03890224

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2027-02-28

Brief 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non-targeted home NIV

Nocturnal home non-invasive ventilation (NIV)

Group Type: ACTIVE_COMPARATOR

home ventilators

Intervention Type: DEVICE

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.

Targeted home NIV

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

Group Type: ACTIVE_COMPARATOR

home ventilators

Intervention Type: DEVICE

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.

Rescue home NIV

home non-invasive ventilation (NIV) on demand

Group Type: ACTIVE_COMPARATOR

home ventilators

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Fondation du Souffle

UNKNOWN

Sponsor Role: collaborator

Clinact

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesus Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,

Locations

Groupe Hospitalier Pitié Salpêtrière-Charles Foix

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Angèle Guilbot

Role: CONTACT

angele.guilbot@multihealthgroup.com

+33-180-13-15-19

Nathalie Gagne

Role: CONTACT

nathalie.gagne@clinact.com

+33-180-13-14-70

Facility Contacts

Jesus² GONZALES-EBERMEJO, Professor

Role: primary

jesus.gonzalez@aphp.fr

+33 1 42 16 78 59

References

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: 10.1186/s13063-020-04672-w.

Reference Type: DERIVED

PMID: 33092618 (View on PubMed)

Other Identifiers

2018-A01872-53

Identifier Type: OTHER

Identifier Source: secondary_id

R2M

Identifier Type: -

Identifier Source: org_study_id