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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180439
Enrollment
8
Registered
2010-08-12
Start date
2009-10-31
Completion date
2010-08-31
Last updated
2010-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Non-invasive ventilation, Chronic Obstructive Pulmonary Disease, Patient-ventilator synchronisation, Sleep study, Polysomnography

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.

Interventions

DEVICEAdjustment 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)

Sponsors

Ligue Pulmonaire Genevoise
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unstable clinical condition

Design outcomes

Primary

MeasureTime frameDescription
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settingsone nightVisual 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

MeasureTime frameDescription
Objective evaluation of efficacy of ventilation after adjustment of ventilator settingsone nightAnalysis of leaks, estimated ventilation, SpO2, TcPCO2, sleep structure, and patient-ventilatory synchronisation and comparison with data under usual settings for ventilator

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026