Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00762398 |
| Other study ID # |
2008-6221 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2008 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
March 2021 |
| Source |
University of California, Irvine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The Masimo monitor can measure hemoglobin level noninvasively and accuratly
Description:
Blood hemoglobin concentration is a very common and essential test to assess patient well
being and the need for blood transfusion. In the perioperative period this measurement is
further more critical mainly due to the acute nature of blood loss and the need for an
immediate response. Currently, hemoglobin concentration is determined by analyzing a blood
sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the
patient discomfort there are additional disadvantages such as infection, dealing with blood
product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of
developing a noninvasive monitor to detect hemoglobin concentrations in real time. The
monitor uses a probe placed on the patient finger that gives hemoglobin concentration
continuously and noninvasively. Masimo Labs is using a technology that resembles the well
accepted and clinically proven pulse-oxymeter.
The study will include surgical patients at the UCI Medical Center, preferably in cases that
are known to involve major blood loss. For these cases, the anesthesia team places an
arterial line for anesthesia purposes. The arterial line is used for continuous blood
pressure measurements and blood draw for the assessment of several indices. We plan to
compare the hemoglobin concentrations measured from blood samples to the Masimo Labs
pulse-hemoglobin level readings.
