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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
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnia

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 7, 2013
Last Updated
November 22, 2013
Sponsor
Medical University of Vienna
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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

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Gas Transfer on ILA-Activve

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