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

This study has been completed.
Sponsor:
Information provided by:
Ligue Pulmonaire Genevoise
ClinicalTrials.gov Identifier:
NCT01180439
First received: August 10, 2010
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Device: Adjustment of ventilator settings (device)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient-Ventilator Interactions During Sleep Under Non-Invasive Ventilation in Severe Stable COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ligue Pulmonaire Genevoise:

Primary Outcome Measures:
  • Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings [ Time Frame: one night ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Objective evaluation of efficacy of ventilation after adjustment of ventilator settings [ Time Frame: one night ] [ Designated as safety issue: No ]
    Analysis of leaks, estimated ventilation, SpO2, TcPCO2, sleep structure, and patient-ventilatory synchronisation and comparison with data under "usual settings" for ventilator


Enrollment: 8
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Adjustment 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180439

Locations
Switzerland
Division of Pulmonary Diseases; Geneva University Hospital
Geneva 11, Geneva, Switzerland, 1211
Division of Pulmonary Diseases; Geneva University Hospital
Geneva 14, Geneva, Switzerland, 1211
Sponsors and Collaborators
Ligue Pulmonaire Genevoise
Investigators
Study Director: Jean-Paul Janssens, MD Division of Pulmonary Diseases; Geneva University Hospital
  More Information

Publications:

Responsible Party: Dan Adler, MD, Division of Pulmonary Diseases, Geneva University Hospital
ClinicalTrials.gov Identifier: NCT01180439     History of Changes
Other Study ID Numbers: CE 09-047
Study First Received: August 10, 2010
Last Updated: August 11, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by Ligue Pulmonaire Genevoise:
Non-invasive ventilation
Chronic Obstructive Pulmonary Disease
Patient-ventilator synchronisation
Sleep study
Polysomnography

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013