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Clinical Trials/NCT02782806
NCT02782806CompletedNot Applicable

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Masimo Corporation2 sites in 1 country368 target enrollmentStarted: April 11, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
368
Locations
2
Primary Endpoint
Accuracy of sensor
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
1 Month to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Test group

Experimental

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

Intervention: Masimo Rad-67 Pulse Oximeter (Device)

Outcomes

Primary Outcomes

Accuracy of sensor

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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