Chronic Obstructive Pulmonary DiseaseNCT01180439
Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation
A study testing Adjustment of ventilator settings (device) in people with Chronic Obstructive Pulmonary Disease, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Adjustment of ventilator settings (device)
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD, with chronic hypercapnic respiratory failure, treated by NIV, in stable clinical condition, aged above 18 years
Who cannot join
- Unstable clinical condition
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Pulmonary Diseases; Geneva University Hospital
Geneva, Canton of Geneva, 1211
About this study
Official title: 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.
Read the 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
- Chronic Obstructive Pulmonary Disease
- Being tested
- Adjustment of ventilator settings (device)
- Keywords
- Non-invasive ventilation, Chronic Obstructive Pulmonary Disease, Patient-ventilator synchronisation, Sleep study, Polysomnography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of ventilator settings (device)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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one night
Secondary outcomes (1)
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
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Genevoise
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Paul Janssens, MD, Study director, Division of Pulmonary Diseases; Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180439
- Sponsor's protocol ID
- CE 09-047
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18579368Adler 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.
PubMed 22051930
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Ventilator Interactions During Sleep Under Non-Invasive Ventilation in Severe Stable COPD
- ClinicalTrials.gov ID
- NCT01180439
- Acronym / sponsor ID
- CE 09-047
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Non-invasive ventilation, Chronic Obstructive Pulmonary Disease, Patient-ventilator synchronisation, Sleep study, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ligue Pulmonaire GenevoiseUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD, with chronic hypercapnic respiratory failure, treated by NIV, in stable clinical condition, aged above 18 years
Key exclusion criteria (1 listed)
- Unstable clinical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | – |
Primary outcome
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings
Time frame: one night
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)
1 secondary outcome
Objective evaluation of efficacy of ventilation after adjustment of ventilator settings
Time frame: one night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
- Background: PubMed 18579368Janssens 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.
- Derived from this study: PubMed 22051930Adler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Janssens, MD study director
Division of Pulmonary Diseases; Geneva University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of ventilator settings (device) in people with Chronic Obstructive Pulmonary Disease, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings (time frame: one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180439, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2010.