NCT03038074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable healthy

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

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 9, 2017

Last Update Submit

May 5, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Collection of high-resolution pulse oximetry and RAM data in pediatric subjects

    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.

    through study completion, an average of 6 months

Study Arms (1)

Test Group

EXPERIMENTAL

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

Device: Pulse Oximeter with respiration rate sensor

Interventions

Pulse Oximeter with respiration rate sensorDEVICE
Test Group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Office of Mohammad T. Bailony

National City, California, 91950, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 31, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

US(1)