NCT03125135

Brief Summary

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable healthy

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

November 12, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

April 14, 2017

Last Update Submit

January 29, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Accuracy of Sensor

    Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.

    1-5 hours

  • Accuracy of Sensor during motion

    Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value.

    1-5 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.

Device: MightySat RX Pulse Oximeter Sensor

Interventions

MightySat RX Pulse Oximeter SensorDEVICE

Noninvasive pulse oximeter finger sensor.

Test Subject

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must understand and consent to be in the study.
  • American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

You may not qualify if:

  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks.
  • Smokers.
  • Subjects who are pregnant.
  • Subjects having either signs or history of peripheral ischemia.
  • Others deemed ineligible by the clinical staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

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 24, 2017

Study Start

November 12, 2014

Primary Completion

December 17, 2014

Study Completion

December 17, 2014

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

US(1)