HypercapniaNCT01997528
Gas Transfer on ILA-Activve
A study testing Change of blood flow or sweep gas flow ( ILA Activve) in people with Hypercapnia, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hypercapnia
- What is being tested?
- Change of blood flow or sweep gas flow ( ILA Activve)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on ILA Activve
- Controlled mechanical ventilation
- No spontaneous breathing
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Dept. of Medicine I, ICU, General Hospital of Vienna
Vienna, State of Vienna, 1090
Thomas Staudinger, MD, +43140400 ext. 4492, thomas.staudinger@meduniwien.ac.at
Thomas Staudinger, MD
About this study
Official title: Efficiency of Gas Exchange Using a Miniaturized Pump Driven Veno-venous Extracorporeal Gas Exchange Device (ILA-Activve)
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.
- Conditions
- Hypercapnia
- Being tested
- Change of blood flow or sweep gas flow ( ILA Activve)
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of blood flow or sweep gas flow ( ILA Activve)Device
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal CO2 elimination by ILA Activve(R) | Experimental | Not described Receives: Device: Change of blood flow or sweep gas flow ( ILA Activve) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood gas analysis
Measured: Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Staudinger, Medical University of Vienna
- Investigators
- Thomas Staudinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997528
- Sponsor's protocol ID
- EK Nr. 1191/2013
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Gas Exchange Using a Miniaturized Pump Driven Veno-venous Extracorporeal Gas Exchange Device (ILA-Activve)
- ClinicalTrials.gov ID
- NCT01997528
- Acronym / sponsor ID
- EK Nr. 1191/2013
- Conditions
- Hypercapnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal CO2 elimination by ILA Activve(R) | Experimental | Device: Change of blood flow or sweep gas flow ( ILA Activve) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient on ILA Activve
- Controlled mechanical ventilation
- No spontaneous breathing
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change of blood flow or sweep gas flow ( ILA Activve) | Device | Extracorporeal CO2 elimination by ILA Activve(R) |
Primary outcome
Blood gas analysis
Time frame: Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept. of Medicine I, ICU, General Hospital of Vienna
Vienna, Austria
Thomas Staudinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of blood flow or sweep gas flow ( ILA Activve) in people with Hypercapnia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood gas analysis (time frame: Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.