Spot-Check Noninvasive Pulse CO-Oximeter Validation

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Device: Masimo Rad-67 Pulse Oximeter

• Registration Number: NCT02782806
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2016-05-12
• Primary Completion: 2016-05-19
• Study Completion: 2016-05-19
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Status Verified: 2019-04
• Disposition First Submitted: 2019-04-01
• Disposition First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Disposition First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	Masimo Rad-67 Pulse Oximeter	All subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin.

Primary Outcome Measures

Name	Time	Method
Accuracy of sensor	Up to 1 hr per subject	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.

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States