Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: Pulse Oximeter with respiration rate sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03038074

BAIL0002

Details and patient eligibility

About

The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.

Enrollment: 200 patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 0 to 5 years old
• Fully developed skin

Exclusion criteria

• Subjects with skin abnormalities at the planned application sites that would interfere with sensor application.
• Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
• Subjects deemed not suitable for the study at the discretion of the investigator

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Test Group

Experimental group

Description:

The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate.

Treatment:

Device: Pulse Oximeter with respiration rate sensor