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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03125018
Other study ID # TR27479-TP16850A
Secondary ID
Status Completed
Phase N/A
First received April 14, 2017
Last updated April 20, 2017
Start date September 30, 2014
Est. completion date October 9, 2014

Study information

Verified date April 2017
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 9, 2014
Est. primary completion date October 9, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Competent non-smoking adults between the ages of 18 and 40 for each series of tests.

- Subjects must understand and consent to be in the study.

- American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
LNCS ADTX Sensor
Noninvasive pulse oximeter sensor.

Locations

Country Name City State
United States Masimo Corporation Irvine California

Sponsors (1)

Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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