Feasibility and Performance Evaluation for INVSENSOR00024

Feasibility and Performance Evaluation of INVSENSOR00024

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.

Study Overview

• Status: Completed
• Conditions: Evaluation of SpO2 Performance
• Intervention / Treatment: Device: RD SET Neo SpO2

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RD SET Neo SpO2; All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.	Device: RD SET Neo SpO2; All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation	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.	up to 8 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HAMM0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No