NCT00762398

Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Masimo monitor can measure hemoglobin level noninvasively and accuratly

Detailed 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.

Conditions

• Adult Patient Undergoing Major Surgery

Interventions

Type	Name	Description
DEVICE	Masimo hemoglobin-meter	Placing a probe on the finger
BIOLOGICAL	drawing blood sample	drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2011-12-01
• First posted: 2008-09-30
• Last updated: 2021-03-29

Locations

1 site across 1 country: United States