NCT03134313

Brief Summary

In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. 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
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2008

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

December 12, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2009

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

April 14, 2017

Results QC Date

May 8, 2017

Last Update Submit

June 28, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of SpHb on R1-25 by Arms Calculation

    Accuracy will 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

    1-5 hours per subject

Study Arms (1)

R1-25 Sensor

EXPERIMENTAL

All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Device: Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Interventions

Rainbow Adhesive Noninvasive R1 Pulse Oximeter SensorDEVICE
R1-25 Sensor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years old
  • Healthy

You may not qualify if:

  • Do not understand the study and the risks involved
  • Deemed ineligible by study test personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Results Point of Contact

Title
Vikram Ramakanth
Organization
Masimo
clinicalresearchdept@masimo.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

April 14, 2017

First Posted

April 28, 2017

Study Start

December 12, 2008

Primary Completion

June 19, 2009

Study Completion

June 19, 2009

Last Updated

July 2, 2017

Results First Posted

July 2, 2017

Record last verified: 2017-06

Locations

US(1)