Gas Transfer on ILA-Activve
Primary Purpose
Hypercapnia
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Change of blood flow or sweep gas flow ( ILA Activve)
Sponsored by
About this trial
This is an interventional treatment trial for Hypercapnia
Eligibility Criteria
Inclusion Criteria:
- Patient on ILA Activve
- Controlled mechanical ventilation
- No spontaneous breathing
Exclusion Criteria:
- Pregnancy
Sites / Locations
- Dept. of Medicine I, ICU, General Hospital of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Extracorporeal CO2 elimination by ILA Activve(R)
Arm Description
Outcomes
Primary Outcome Measures
Blood gas analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT01997528
First Posted
November 7, 2013
Last Updated
November 22, 2013
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01997528
Brief Title
Gas Transfer on ILA-Activve
Official Title
Efficiency of Gas Exchange Using a Miniaturized Pump Driven Veno-venous Extracorporeal Gas Exchange Device (ILA-Activve)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen cannula are measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extracorporeal CO2 elimination by ILA Activve(R)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Change of blood flow or sweep gas flow ( ILA Activve)
Primary Outcome Measure Information:
Title
Blood gas analysis
Time Frame
Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient on ILA Activve
Controlled mechanical ventilation
No spontaneous breathing
Exclusion Criteria:
- Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Medicine I, ICU, General Hospital of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, MD
Phone
+43140400
Ext
4492
Email
thomas.staudinger@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, MD
12. IPD Sharing Statement
Learn more about this trial
Gas Transfer on ILA-Activve
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