Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Pulse Oximeter with respiration rate sensor

• Registration Number: NCT03038074
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Disposition First Submitted: 2018-03-14
• Disposition First Submitted QC: 2018-03-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Disposition First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Collection of high-resolution pulse oximetry and RAM data in pediatric subjects	through study completion, an average of 6 months	The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals 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.

Trial Locations

Locations (1)

Medical Office of Mohammad T. Bailony; 🇺🇸 National City, California, United States