Back to resultsProspective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure (Boussignac)
Primary Purpose
Acute-on-chronic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
non- invasive ventilation
Sponsored by
About this trial
This is an interventional supportive care trial for Acute-on-chronic Respiratory Failure focused on measuring non-invasion ventilation, Boussignac
Eligibility Criteria
Inclusion Criteria:
- 7,25 ≤ pH ≤ 7,35
- PaCO2 ≥ 45 mmHg
Exclusion Criteria:
- pH < 7,24
- incapable of collaboration
Sites / Locations
- RoMed Klinikum Rosenheim
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-invasive ventilation
Arm Description
Outcomes
Primary Outcome Measures
Sinking pCO2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01788345
Brief Title
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vygon GmbH & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-on-chronic Respiratory Failure
Keywords
non-invasion ventilation, Boussignac
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non-invasive ventilation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
non- invasive ventilation
Other Intervention Name(s)
Boussignac
Intervention Description
non-invasive bi-level ventilation with IPAP and EPAP.
Primary Outcome Measure Information:
Title
Sinking pCO2
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
7,25 ≤ pH ≤ 7,35
PaCO2 ≥ 45 mmHg
Exclusion Criteria:
pH < 7,24
incapable of collaboration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Budweiser, PD
Official's Role
Study Director
Facility Information:
Facility Name
RoMed Klinikum Rosenheim
City
Rosenheim
State/Province
Bavarian
ZIP/Postal Code
83022
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.cebp.nl/vault_public/filesystem
Description
Boussignac, non-invasive ventilation
Learn more about this trial
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
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