---
title: Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation
nct_id: NCT01180439
overall_status: COMPLETED
phase: NA
sponsor: Ligue Pulmonaire Genevoise
study_type: INTERVENTIONAL
primary_condition: Chronic Obstructive Pulmonary Disease
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01180439.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01180439"
ct_last_update_post_date: 2010-08-12
last_seen_at: "2026-05-12T07:14:07.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01180439](https://clinicaltrials.gov/study/NCT01180439)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** Ligue Pulmonaire Genevoise
- **Conditions:** Chronic Obstructive Pulmonary Disease
- **Start Date:** 2009-10
- **Completion Date:** 2010-08
- **CT.gov Last Update:** 2010-08-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Interventions

- **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)

## Primary Outcomes

- **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)

## Secondary Outcomes

- **Objective evaluation of efficacy of ventilation after adjustment of ventilator settings** _(time frame: one night)_

## Locations (1)

- Division of Pulmonary Diseases; Geneva University Hospital, Geneva, Canton of Geneva, Switzerland

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.division of pulmonary diseases; geneva university hospital|geneva|canton of geneva|switzerland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01180439*  
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