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LiDCO Monitor Study

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ClinicalTrials.gov Identifier: NCT01567371
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Device: LiDCO rapid monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood
Study Start Date : March 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: LiDCO rapid monitor Device: LiDCO rapid monitor
Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.



Primary Outcome Measures :
  1. Difference in Pulse Pressure Variability From Baseline to Post-ANH [ Time Frame: 1 Day ]
    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.


Secondary Outcome Measures :
  1. Difference in Stroke Volume Variability From Baseline to Post ANH. [ Time Frame: 1 Day ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567371


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital

Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01567371     History of Changes
Other Study ID Numbers: IRB12-00096
First Posted: March 30, 2012    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016