Spontaneous Ventilation Mode and Controlled Ventilation Mode and Simulator Ventilation Mode in Obesity Hypoventilation Syndrome (OHS) and Chest Wall Disorders and Neuromuscular Disorders - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain, 08025
    - Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: N/A
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transcutaneous carbon dioxide measurement Time Frame: One hour	One hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Inspiratory-time/total-respiratory-cycle value Time Frame: One hour	One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

Principal Investigator: Pedro A Anton Albisu, Medical Dr, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Study Chair: Patricia Peñacoba Toribio, Physician, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Study Chair: Macarena Segura, Physiotherapist, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Estimated)

December 1, 2016

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria