Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Obesity Hypoventilation Syndrome (OHS) Clinical Trial

Official title:

Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01991535
• Other study ID #: IIBSP-VEN-2013-23
• Status: Withdrawn
• Phase: N/A

Study information

• Verified date: October 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall Disorders
• Hypoventilation
• Neuromuscular Diseases
• Neuromuscular Disorders
• Obesity Hypoventilation Syndrome
• Obesity Hypoventilation Syndrome (OHS)

Intervention

Device:
• Spontaneous Ventilation Mode
Respiratory rate and duration of inspiration are controlled by the patient. Device model: Stellar 150® (ResMed, Australia).
• 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).
• Simulator Ventilation Mode
Ventilator maintains a continuous positive airway pressure during the entire cycle. Device model: Stellar 150® (ResMed, Australia).

Locations

Country	Name	City	State
Spain	Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous carbon dioxide measurement		One hour
Secondary	Inspiratory-time/total-respiratory-cycle value		One hour