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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Adjustment of ventilator settings (device)

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva
    • Geneva 11, Geneva, Switzerland, 1211
      • Division of Pulmonary Diseases; Geneva University Hospital
    • Geneva 14, Geneva, Switzerland, 1211
      • Division of Pulmonary Diseases; Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable clinical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings	Visual analogic scale (VAS) of morning dyspnea, and questionnaire evaluating 8 items of comfort of ventilation (Janssens JP et al; 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)	one night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective evaluation of efficacy of ventilation after adjustment of ventilator settings	Analysis of leaks, estimated ventilation, SpO2, TcPCO2, sleep structure, and patient-ventilatory synchronisation and comparison with data under "usual settings" for ventilator	one night

Collaborators and Investigators

• Sponsor: Ligue Pulmonaire Genevoise
• Investigators: Study Director: Jean-Paul Janssens, MD, Division of Pulmonary Diseases; Geneva University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 10, 2010
• First Submitted That Met QC Criteria: August 11, 2010
• First Posted (Estimate): August 12, 2010

Study Record Updates

• Last Update Posted (Estimate): August 12, 2010
• Last Update Submitted That Met QC Criteria: August 11, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Polysomnography; Non-invasive ventilation; Chronic Obstructive Pulmonary Disease; Patient-ventilator synchronisation; Sleep study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CE 09-047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No