Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Jul 2019
Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
July 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedJune 20, 2024
June 1, 2024
5 years
March 15, 2019
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
admission-free survival
defined as time from randomisation to hospital admission in relation with severe exacerbation of COPD or death from any cause, whichever event occurred first, estimated using the Kaplan-Meier method. If neither event occurs, then time will be taken from day randomisation to the last known follow up visit. If withdrawal occurs prior to death, time will be taken from the day of randomisation to day of withdrawal.
0-36 months
Secondary Outcomes (15)
Overall survival
0-36 months
Frequency of exacerbations requiring hospitalization
12 months
Frequency of exacerbations resulting in physician directed treatment
12 months
Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide
0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of Exacerbation based on changes in arterial partial pressure of oxygen
0, 1, 3, 6, 12, 18, 24, 30 and 36 months
- +10 more secondary outcomes
Study Arms (4)
Control group
NO INTERVENTIONno home non-invasive ventilation (NIV), only hospital NIV
Non-targeted home NIV
ACTIVE COMPARATORNocturnal home non-invasive ventilation (NIV)
Targeted home NIV
ACTIVE COMPARATORNocturnal home non-invasive ventilation (NIV) with high monitoring
Rescue home NIV
ACTIVE COMPARATORhome non-invasive ventilation (NIV) on demand
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)\<65%;
- \) AHRF (pH\<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
- \) 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%).
You may not qualify if:
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinactlead
- Assistance Publique - Hôpitaux de Pariscollaborator
- Fondation du Soufflecollaborator
Study Sites (1)
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, Île-de-France Region, 75651, France
Related Publications (1)
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.
PMID: 33092618DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Gonzalez, MD
Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 26, 2019
Study Start
July 4, 2019
Primary Completion
June 15, 2024
Study Completion (Estimated)
February 28, 2027
Last Updated
June 20, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share