NCT03124823

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
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2015

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

August 28, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2015

Completed
1.6 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
3 months until next milestone

Results Posted

Study results publicly available

July 28, 2017

Completed
Last Updated

July 28, 2017

Status Verified

June 1, 2017

Enrollment Period

11 days

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 Sensor by Arms Calculation

    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(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement 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

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor

Device: Rainbow DCI Sensor

Interventions

Rainbow DCI SensorDEVICE

Noninvasive pulse oximeter sensor

Test Subject

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Competent non-smoking adults between the ages of 18 and 45 for each series of tests.
  • Must weigh a minimum of 110 pounds and no more than 250 pounds unless subject is over 6 feet tall.
  • Subjects must understand and consent to be in the study.
  • American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
  • Subjects with hemoglobin greater than or equal to 11 g/dL.

You may not qualify if:

  • Subjects with polished, gel or acrylic nails.
  • Subjects with damaged and/or finger nail deformities.
  • Subjects who have had caffeine consumption the day of the study.
  • Subjects who have taken pain medication 24 hours before the study.
  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks.
  • Subjects who smoke.
  • Subjects who use recreational drugs.
  • Subjects who are pregnant or nursing.
  • Subjects having either signs or history of peripheral ischemia.
  • Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
  • Subjects with psychiatric conditions or are on psychiatric medications.
  • Subjects who have had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynological surgeries.
  • Subjects who have had minor surgery or conditions in the past two months including but not limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma donation, skin biopsy/ procedures, root canal, fractures, eye surgery, and other minor procedures.
  • Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest congestion will have a 2 week waiting period from the time of finishing medications or must have no more symptoms.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

Title
Tala Harake
Organization
Masimo
studies@masimo.com

Publication Agreements

PI is Sponsor Employee
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 24, 2017

Study Start

August 28, 2015

Primary Completion

September 8, 2015

Study Completion

September 8, 2015

Last Updated

July 28, 2017

Results First Posted

July 28, 2017

Record last verified: 2017-06

Locations

US(1)