NCT02782806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

May 12, 2016

Last Update Submit

April 1, 2019

Conditions

Anemia

Keywords

NoninvasivePulseCO-OximeterValidation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Test group

EXPERIMENTAL

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

Interventions

Masimo Rad-67 Pulse OximeterDEVICE

Noninvasive pulse oximeter

Test group

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 25, 2016

Study Start

April 11, 2016

Primary Completion

May 19, 2016

Study Completion

May 19, 2016

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

US(1)