LiDCO Monitor Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01567371
First received: March 26, 2012
Last updated: March 16, 2016
Last verified: March 2016

March 26, 2012
March 16, 2016
March 2012
December 2014   (final data collection date for primary outcome measure)
Difference in Pulse Pressure Variability From Baseline to Post-ANH [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Pulse pressure variability [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
The study would validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) in measuring pulse pressure variability during a period of phlebotomy and graded blood loss.
Complete list of historical versions of study NCT01567371 on ClinicalTrials.gov Archive Site
Difference in Stroke Volume Variability From Baseline to Post ANH. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.
Stroke volume variability [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
The study would validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) in measuring stroke volume variability during a period of phlebotomy and graded blood loss.
Not Provided
Not Provided
 
LiDCO Monitor Study
Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cardiac Surgery
Device: LiDCO rapid monitor
Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.
Experimental: LiDCO rapid monitor
Intervention: Device: LiDCO rapid monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01567371
IRB12-00096
No
Not Provided
Not Provided
Joseph D. Tobias, Nationwide Children's Hospital
Nationwide Children's Hospital
Not Provided
Not Provided
Nationwide Children's Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP