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Clinical Trials/NCT01991535
NCT01991535
Withdrawn
Not Applicable

Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 countryNovember 25, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Disorders
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
1
Primary Endpoint
Transcutaneous carbon dioxide measurement
Status
Withdrawn
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 25, 2013
End Date
December 2016
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Transcutaneous carbon dioxide measurement

Time Frame: One hour

Secondary Outcomes

  • Inspiratory-time/total-respiratory-cycle value(One hour)

Study Sites (1)

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