NCT00920569

Brief Summary

This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

June 11, 2009

Last Update Submit

May 25, 2016

Conditions

RecirculationOxygenator Blood VolumeCardiac OutputVenoarterial Extracorporeal Membrane OxygenationVenovenous Extracorporeal Membrane Oxygenation

Keywords

cardiac outputrecirculationoxygenator blood volumevenoarterial extracorporeal membrane oxygenationvenovenous extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (1)

  • Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation.

    Duration of extracorporeal membrane oxygenation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Measurement of cardiac output in venoarterial extracorporeal membrane oxygenation patients, recirculation in venovenous extracorporeal membrane oxygenation patients and oxygenator blood volume in venoarterial and venovenous extracorporeal membrane oxygenation patients.

You may qualify if:

  • Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation.

You may not qualify if:

  • Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan, Medical School

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Jonathan Haft, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Nikolai M Krivitski, PhD, DSc

    Transonic Systems Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 15, 2009

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)