Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

N/AWithdrawnNCT01991535

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

SINGLE

Conditions

Neuromuscular Disorders Chest Wall Disorders Obesity Hypoventilation Syndrome (OHS)

Interventions

Spontaneous Ventilation ModeDEVICE

Respiratory rate and duration of inspiration are controlled by the patient. Device model: Stellar 150® (ResMed, Australia).

Controlled Ventilation ModeDEVICE

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).

Simulator Ventilation ModeDEVICE

Ventilator maintains a continuous positive airway pressure during the entire cycle. Device model: Stellar 150® (ResMed, Australia).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

Transcutaneous carbon dioxide measurement

Time frame: One hour

Secondary Outcomes

Inspiratory-time/total-respiratory-cycle value

Time frame: One hour

Data from ClinicalTrials.gov

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