Spot-Check Noninvasive Pulse CO-Oximeter Validation

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Device: Masimo Rad-67 Pulse Oximeter

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Age: Greater than one month
• Weight: Greater than or equal to 3kg
• Any racial or ethnic group
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
• If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

Exclusion Criteria:

• Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
• Subjects deemed not suitable for the study at the discretion of the investigator
• Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; All subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin.	Device: Masimo Rad-67 Pulse Oximeter; Noninvasive pulse oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of sensor	Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.	Up to 1 hr per subject

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2016
• Primary Completion (Actual): May 19, 2016
• Study Completion (Actual): May 19, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Validation; Noninvasive; Pulse; CO-Oximeter
• Other Study ID Numbers: TORR0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes