Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: MightySat RX Pulse Oximeter Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03125135

TR27761-TP16850A

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Competent non-smoking adults

Inclusion Criteria:

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Test Subject

Experimental group

Description:

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

Treatment:

Device: MightySat RX Pulse Oximeter Sensor