Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

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Detailed Description

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Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).

Conditions

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Neuromuscular Disorders Chest Wall Disorders Obesity Hypoventilation Syndrome (OHS)

Study Design

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Allocation Method

NA

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Interventions

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Spontaneous Ventilation Mode

Respiratory rate and duration of inspiration are controlled by the patient.

Device model: Stellar 150® (ResMed, Australia).

Intervention Type DEVICE

Controlled Ventilation Mode

Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles.

Device model: Stellar 150® (ResMed, Australia).

Intervention Type DEVICE

Simulator Ventilation Mode

Ventilator maintains a continuous positive airway pressure during the entire cycle.

Device model: Stellar 150® (ResMed, Australia).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
* Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
* Clinically stable (within the previous month).
* Patients without previous NonInvasive Mechanical Ventilation treatment.

Exclusion Criteria

* Clinical exacerbation.
* Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio \< 70% or Sleep Apnea-Hypopnea Syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No