Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Not Applicable

Completed

• Conditions: Pediatric ALL; Anemia; Healthy
• Interventions: Device: Rad-67 Pulse oximeter

• Registration Number: NCT02930850
• Lead Sponsor: Masimo Corporation

Brief Summary

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Detailed Description

The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• 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: 447

Inclusion Criteria

• Age: Greater than one month
• Weight: Greater than or equal to 3kg
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

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.
• Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test subjects	Rad-67 Pulse oximeter	All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.

Primary Outcome Measures

Name	Time	Method
Accuracy of hemoglobin measurement	Up to 2 hours 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 (7)

Site 2; 🇺🇸 Irvine, California, United States

Site 6; 🇺🇸 Torrance, California, United States

Site 4; 🇺🇸 Burbank, California, United States

Site 5; 🇺🇸 Burbank, California, United States

Site 7; 🇺🇸 Lake Forest, California, United States

Site 3; 🇺🇸 National City, California, United States

Site 1; 🇺🇸 Charlotte, North Carolina, United States