LiDCO Monitor Study

Cardiac Surgery Clinical Trial

Official title:

Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567371
• Other study ID #: IRB12-00096
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: May 14, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse pressure variability	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.	1 Day	No
Secondary	Stroke volume variability	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.	1 Day	No