SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

Masimo

Status: Completed

Conditions: Spo2

Treatments: Device: Masimo INVSENSOR00061

Study type: Interventional

Funder types: Industry

Identifiers

NCT05896267

BAIL0003

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 37 weeks to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Masimo INVSENSOR00061

Experimental group

Description:

Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.

Treatment:

Device: Masimo INVSENSOR00061