Actively Recruiting
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Led by Clinact · Updated on 2024-06-20
400
Participants Needed
1
Research Sites
399 weeks
Total Duration
On this page
Sponsors
C
Clinact
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1) <65%
- Acute hypercapnic respiratory failure (AHRF) with pH <7.35 and PaCO2 ≥45 mm Hg treated more than 24 hours with ventilation (non-invasive or invasive)
- Between 48 hours and 2 weeks with pH >7.35 and PaCO2 >45 mm Hg after NIV withdrawal during daytime at rest without oxygen or ventilatory support (or with oxygen if immediate desaturation below 80% occurs without it)
You will not qualify if you...
- Current treatment with chronic NIV or continuous positive airway pressure (CPAP) device
- Primary diagnosis of restrictive lung disease causing hypercapnia, except if FEV1/FVC <60% and FEV1 <50% with obstructive defect
- Body mass index (BMI) greater than 35 kg/m2
- Use of sedative medication causing hypercapnia (more than 3 drugs or over 20 mg morphine per day)
- Diagnosis of obstructive sleep apnea syndrome with apnea-hypopnea index over 30 per hour
- Cognitive impairment preventing informed consent
- Pregnancy
- Tobacco use less than 10 pack-years
- Psychiatric disease requiring antipsychotic medication, ongoing drug or alcohol addiction treatment, or unstable living situation
- Unstable coronary artery syndrome
- Age under 18 years
- Inability to follow study protocol
- Expected survival less than 12 months due to conditions other than COPD
- Intensive care unit stay longer than 10 days
- Not affiliated with national health insurance
- Under legal protection such as guardianship or judicial protection for adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, Île-de-France Region, France, 75651
Actively Recruiting
Research Team
A
Angèle Guilbot
CONTACT
N
Nathalie Gagne
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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