SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

Not Applicable

Completed

• Conditions: Spo2
• Interventions: Device: Masimo INVSENSOR00061

• Registration Number: NCT05896267
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Results First Submitted: 2024-04-08
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Results First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
SpO2 Accuracy of INVSENSOR00061	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	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.

Trial Locations

Locations (1)

Bailony Pediatrics; 🇺🇸 National City, California, United States