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

NCT ID: NCT00762398

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-12-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patient undergoing a surgery

Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes

Masimo hemoglobin-meter

Intervention Type: DEVICE

Placing a probe on the finger

drawing blood sample

Intervention Type: BIOLOGICAL

drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)

Interventions

Masimo hemoglobin-meter

Placing a probe on the finger

Intervention Type: DEVICE

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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adult having surgery with arterial line

Exclusion Criteria

• Upper extremities surgery
• Pregnant women
• Children

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Labs

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abraham Rosenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Univeristy of California Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2008-6221

Identifier Type: -

Identifier Source: org_study_id