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Completed

NCT Number: NCT03570255

Feasibility and Performance Evaluation for 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.

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Key information

Conditions

Evaluation of SpO2 Performance

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

RD SET Neo SpO2

Device

All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.

Primary outcomes

  1. Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

Feasibility and Performance Evaluation of INVSENSOR00024

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
Feb 20, 2020

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.

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