Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991535

Enrollment

Registered

2013-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-21

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

Conditions

Chest Wall Disorders, Neuromuscular Disorders, Obesity Hypoventilation Syndrome (OHS)

Brief summary

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.

Detailed description

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

Interventions

DEVICESpontaneous Ventilation Mode

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

DEVICEControlled 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).

DEVICESimulator Ventilation Mode

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

Study design

Allocation

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Transcutaneous carbon dioxide measurement	One hour

Secondary

Measure	Time frame
Inspiratory-time/total-respiratory-cycle value	One hour

Countries

Spain

Outcome results

None listed

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