Overview

This trial is active, not recruiting.

Condition acute-on-chronic respiratory failure
Treatment non- invasive ventilation
Sponsor Vygon GmbH & Co. KG
Start date February 2013
End date August 2013
Trial size 44 participants
Trial identifier NCT01788345, 445-12

Summary

The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
non- invasive ventilation Boussignac
non-invasive bi-level ventilation with IPAP and EPAP.

Primary Outcomes

Measure
Sinking pCO2
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - 7,25 ≤ pH ≤ 7,35 - PaCO2 ≥ 45 mmHg Exclusion Criteria: - pH < 7,24 - incapable of collaboration

Additional Information

Official title Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Vygon GmbH & Co. KG.