LiDCO Monitor Study
This study is enrolling participants by invitation only.
Sponsor:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01567371
First received: March 26, 2012
Last updated: March 29, 2012
Last verified: March 2012
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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.
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 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 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 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013