Feasibility and Performance Evaluation for INVSENSOR00024

Not Applicable

Completed

• Conditions: Evaluation of SpO2 Performance
• Interventions: Device: RD SET Neo SpO2

• Registration Number: NCT03570255
• Lead Sponsor: Masimo Corporation

Brief Summary

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study Start: 2018-06-25
• Study First Posted: 2018-06-26
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-08
• Status Verified: 2020-02
• Results First Submitted: 2020-02-04
• Results First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Results First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Less than or equal to 1 month of age
• Weight <3kg
• Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria

• Subjects with underdeveloped skin
• Subjects with abnormalities at the planned application sites that would interfere with system measurements
• Subjects with known allergic reactions to foam/rubber products and adhesive tape
• Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD SET Neo SpO2	RD SET Neo SpO2	All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.

Primary Outcome Measures

Name	Time	Method
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation	up to 8 hours	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States