SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.

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Key information

Conditions

SpO2

Age range

37 week–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bailony Pediatrics

National City, California, 91950, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Subject is a full-term newborn (37 weeks) to 18 months of age.

Exclusion criteria

• Subject has underdeveloped skin.

Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
Subject is not suitable for the investigation at the discretion of the Investigator.

Treatment and study plan

Masimo INVSENSOR00061

Device

Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )

Primary outcomes

SpO2 Accuracy of INVSENSOR00061

Time frame: Approximately 15 minutes

SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Pulse Rate Accuracy of INVSENSOR00061

Time frame: Approximately 15 minutes

Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 9, 2023
Registry last updated: Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed