Trials / Terminated
TerminatedNCT03934749
Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease
Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Besancon · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known. In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation. The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non Invasive Ventilation | NIV using standard mode or Lowenstein mode |
Timeline
- Start date
- 2019-06-27
- Primary completion
- 2020-06-27
- Completion
- 2020-09-27
- First posted
- 2019-05-02
- Last updated
- 2021-08-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03934749. Inclusion in this directory is not an endorsement.