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NCT02930850 Clinical Trial

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Healthy Clinical Trial

Official title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02930850
Other study ID # TORR0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date October 2016

Study information
Verified date April 2019
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 447
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Rad-67 Pulse oximeter
Noninvasive pulse oximeter that measures hemoglobin

Locations
Country Name City State
United States Site 4 Burbank California
United States Site 5 Burbank California
United States Site 1 Charlotte North Carolina
United States Site 2 Irvine California
United States Site 7 Lake Forest California
United States Site 3 National City California
United States Site 6 Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of hemoglobin measurement 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 2 hours per subject
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