Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure

Acute-on-chronic Respiratory Failure Clinical Trial

— Boussignac  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01788345
• Other study ID #: 445-12
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2013
• Last updated: February 7, 2013
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Vygon GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 7,25 = pH = 7,35

• PaCO2 = 45 mmHg

Exclusion Criteria:

• pH < 7,24

• incapable of collaboration

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute-on-chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• non- invasive ventilation
non-invasive bi-level ventilation with IPAP and EPAP.

Locations

Country	Name	City	State
Germany	RoMed Klinikum Rosenheim	Rosenheim	Bavarian

Sponsors (1)

Lead Sponsor	Collaborator
Vygon GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinking pCO2		6 months	No