Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 9:20 PM
Study NCT ID:
NCT00920569
Status:
TERMINATED
Last Update Posted:
2016-05-27
First Post:
2009-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation
Sponsor:
Transonic Systems Inc.
Organization:
Study Overview
Official Title:
Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study site collaborators withdrew from participating due to time constraints.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R43HL082022-01 | NIH | None | https://reporter.nih.gov/quic… | View |