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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01180439
• Lead Sponsor: Ligue Pulmonaire Genevoise

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.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-11
• Last Update Submitted: 2010-08-11
• Study First Posted: 2010-08-12
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective evaluation of efficacy of nocturnal ventilation after adjusting ventilator settings	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Pulmonary Diseases; Geneva University Hospital; 🇨🇭 Geneva 14, Geneva, Switzerland