Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Adjustment of ventilator settings (device)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Non-invasive ventilation, Chronic Obstructive Pulmonary Disease, Patient-ventilator synchronisation, Sleep study, Polysomnography
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
Sites / Locations
- Division of Pulmonary Diseases; Geneva University Hospital
- Division of Pulmonary Diseases; Geneva University Hospital
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01180439
First Posted
August 10, 2010
Last Updated
August 11, 2010
Sponsor
Ligue Pulmonaire Genevoise
1. Study Identification
Unique Protocol Identification Number
NCT01180439
Brief Title
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
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ligue Pulmonaire Genevoise
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Non-invasive ventilation, Chronic Obstructive Pulmonary Disease, Patient-ventilator synchronisation, Sleep study, Polysomnography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Adjustment of ventilator settings (device)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings
Description
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)
Time Frame
one night
Secondary Outcome Measure Information:
Title
Objective evaluation of efficacy of ventilation after adjustment of ventilator settings
Description
Analysis of leaks, estimated ventilation, SpO2, TcPCO2, sleep structure, and patient-ventilatory synchronisation and comparison with data under "usual settings" for ventilator
Time Frame
one night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Janssens, MD
Organizational Affiliation
Division of Pulmonary Diseases; Geneva University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Division of Pulmonary Diseases; Geneva University Hospital
City
Geneva 11
State/Province
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Division of Pulmonary Diseases; Geneva University Hospital
City
Geneva 14
State/Province
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18579368
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.
Results Reference
background
PubMed Identifier
22051930
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.
Results Reference
derived
Learn more about this trial
Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation
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