Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation

Terminated

• Conditions: Venoarterial Extracorporeal Membrane Oxygenation; Cardiac Output; Venovenous Extracorporeal Membrane Oxygenation; Oxygenator Blood Volume; Recirculation

• Registration Number: NCT00920569
• Lead Sponsor: Transonic Systems Inc.

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.

Detailed Description

At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the extracorporeal circuit.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

• Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation.	Duration of extracorporeal membrane oxygenation

Trial Locations

Locations (1)

University of Michigan, Medical School; 🇺🇸 Ann Arbor, Michigan, United States