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LiDCO Monitor Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567371
First Posted: March 30, 2012
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
  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: 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

Further study details as provided by Joseph D. Tobias, Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 30
Study Start Date: March 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: March 26, 2012
First Posted: March 30, 2012
Results First Submitted: March 16, 2016
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016