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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Terminated

Conditions

Adult Patient Undergoing Major Surgery

Treatments

Device: Masimo hemoglobin-meter
Biological: drawing blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT00762398
2008-6221

Details and patient eligibility

About

The Masimo monitor can measure hemoglobin level noninvasively and accuratly

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult having surgery with arterial line

Exclusion criteria

  • Upper extremities surgery
  • Pregnant women
  • Children

Trial design

40 participants in 1 patient group

Adult patient undergoing a surgery
Description:
Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes
Treatment:
Biological: drawing blood sample
Device: Masimo hemoglobin-meter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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