Trials / Terminated
TerminatedNCT03584269
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.
Detailed description
This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NIV Device + LTOT | Respiratory assistance by a facial mask without intubation or tracheotomy |
| DEVICE | LTOT | Long term oxygenatory tyherapy without NIV |
Timeline
- Start date
- 2018-06-28
- Primary completion
- 2018-07-09
- Completion
- 2019-09-23
- First posted
- 2018-07-12
- Last updated
- 2021-02-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03584269. Inclusion in this directory is not an endorsement.