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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01991535
Other study ID # IIBSP-VEN-2013-23
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

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
Health authority
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Status Withdrawn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. completion date
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

Study Design


Related Conditions & MeSH terms


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
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