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 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Cardiac Surgery
Device: LiDCO rapid monitor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01567371

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

No publications provided

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
Study First Received: March 26, 2012
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014