Clinical trial NCT01180439: Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation
Official title: Patient-Ventilator Interactions During Sleep Under Non-Invasive Ventilation in Severe Stable COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Non-invasive ventilation
Chronic Obstructive Pulmonary Disease
Patient-ventilator synchronisation
Sleep study
Polysomnography
Lead sponsor: Ligue Pulmonaire Genevoise
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* COPD, with chronic hypercapnic respiratory failure, treated by NIV, in stable clinical condition, aged above 18 years

Exclusion Criteria:

* Unstable clinical condition

Primary outcomes:
measure: Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings
timeFrame: one night
Secondary outcomes:
measure: Objective evaluation of efficacy of ventilation after adjustment of ventilator settings
timeFrame: one night
Other outcomes:
Locations:
city: Geneva 11
country: Switzerland
facility: Division of Pulmonary Diseases; Geneva University Hospital
state: Geneva
city: Geneva 14
country: Switzerland
facility: Division of Pulmonary Diseases; Geneva University Hospital
state: Geneva
Study officials:
affiliation: Division of Pulmonary Diseases; Geneva University Hospital
name: Jean-Paul Janssens, MD
role: STUDY_DIRECTOR
References:
citation: Janssens JP, Metzger M, Sforza E. Impact of volume targeting on efficacy of bi-level non-invasive ventilation and sleep in obesity-hypoventilation. Respir Med. 2009 Feb;103(2):165-72. doi: 10.1016/j.rmed.2008.03.013. Epub 2008 Jun 24.
citation: Adler D, Perrig S, Takahashi H, Espa F, Rodenstein D, Pepin JL, Janssens JP. Polysomnography in stable COPD under non-invasive ventilation to reduce patient-ventilator asynchrony and morning breathlessness. Sleep Breath. 2012 Dec;16(4):1081-90. doi: 10.1007/s11325-011-0605-y. Epub 2011 Nov 4.