NCT00920062

Brief Summary

This study is to test the usefulness of ultrasound dilution recirculation measurements in patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound dilution measurements determine the efficiency of support provided by venovenous extracorporeal membrane oxygenation. At the present time there are no other devices available to make recirculation measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 years 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
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

June 11, 2009

Last Update Submit

May 25, 2016

Conditions

Venovenous Extracorporeal Membrane OxygenationRecirculation

Keywords

recirculationultrasound dilutionvenovenous extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (1)

  • Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.

    Duration of venovenous extracorporeal membrane oxygenation

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.

You may qualify if:

  • Patients between 0 and 21 years of age
  • Patients receiving venovenous extracorporeal membrane oxygenation as treatment.

You may not qualify if:

  • Patients over 21 years of age
  • Patients not receiving venovenous extracorporeal membrane oxygenation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crouse Hospital

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Clements D, Primmer J, Ryman P, Marr B, Searles B, Darling E. Measurements of recirculation during neonatal veno-venous extracorporeal membrane oxygenation: clinical application of the ultrasound dilution technique. J Extra Corpor Technol. 2008 Sep;40(3):184-7.

    PMID: 18853830BACKGROUND

Study Officials

  • Nikolai M Krivitski, PhD, DSc

    Transonic Systems Inc.

    PRINCIPAL INVESTIGATOR

  • Bonnie L Marr, MD

    Crouse Hospital

    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

June 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)