Gas Transfer on ILA-Activve | NCT01997528

Studies
Gas Transfer on ILA-Activve

NCT01997528

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Nov 28, 2013Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Hypercapnia

Interventions

Change of blood flow or sweep gas flow ( ILA Activve)

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2014Estimated

Completion Date

Not provided

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2013

Last Update Posted Date

Nov 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extracorporeal CO2 elimination by ILA Activve(R)	Experimental		Device: Change of blood flow or sweep gas flow ( ILA Activve)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Change of blood flow or sweep gas flow ( ILA Activve)	Device		Extracorporeal CO2 elimination by ILA Activve(R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood gas analysis		Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient on ILA Activve
Controlled mechanical ventilation
No spontaneous breathing

Exclusion Criteria:

- Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Staudinger, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Medicine I, ICU, General Hospital of Vienna	Recruiting	Vienna	State of Vienna	1090	Austria

Type	Date	Date Unknown
Release	Aug 15, 2018
Reset	Jan 25, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 15, 2018			Jan 25, 2019

Condition Browse Module

MeSH Terms

ID	Term
D006935	Hypercapnia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided