LiDCO Monitor Study

March 16, 2016 updated by: Joseph D. Tobias, Nationwide Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IRB12-00096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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