Clinical Trials Directory

Trials / Completed

CompletedNCT01180439

Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation

Patient-Ventilator Interactions During Sleep Under Non-Invasive Ventilation in Severe Stable COPD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Ligue Pulmonaire Genevoise · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Non-invasive ventilation (NIV) in severe hypercapnic Chronic Obstructive Pulmonary Diseases (COPD) may be associated - during sleep - with recurrent episodes of patient ventilatory asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.Polysomnography (PSG) under NIV is necessary to detect these events. Adjusting ventilator settings according to respiratory events detected by PSG with NIV may improve quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.

Detailed description

Patients under NIV for hypercapnic COPD have several reasons to develop patient-ventilatory asynchrony: delayed cycling, and insufficient expiratory time may induce progressive dynamic hyperinflation, and increase intrinsic positive end-expiratory pressure (PEEPi); too high levels of pressure support may also contribute to dynamic hyperinflation. Increase in PEEPi is associated with two respiratory events: unrewarded inspiratory efforts, and auto-triggering. Our hypotheses are: 1/that these events occur frequently in COPD under NIV and that they are not detected by medical history or usual monitoring tools (SpO2; PtcCO2); 2/ that they can be easily detected by polysomnography; 3/ that simple adjustments of ventilator parameters aiming to reduce dynamic hyperinflation and unrewarded inspiratory efforts may improve efficacy of ventilation, quality of sleep and comfort of treatment. The present study compares the results of two consecutive sleep studies: 1.PSG under NIV in severe stable COPD under "usual ventilator settings" with 2.PSG under NIV after adapting ventilator settings to results of initial PSG.

Conditions

Interventions

TypeNameDescription
DEVICEAdjustment of ventilator settings (device)Decrease in pressure support, increase in respiratory back-up rate, increase in expiratory positive airway pressure (EPAP) to counteract effect of PEEPi, and adjustment of cycling (at higher percentage of peak inspiratory flow)

Timeline

Start date
2009-10-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2010-08-12
Last updated
2010-08-12

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01180439. Inclusion in this directory is not an endorsement.