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N/A N=28 Other

Feasibility and Performance Evaluation for INVSENSOR00024

Evaluation of SpO2 Performance

Bottom Line

View on ClinicalTrials.gov: NCT03570255 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation — 2.1 percent of oxygen saturated hemoglobin

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
RD SET Neo SpO2 (Device)
Age
Pediatric
Sex
All
Sponsor
Masimo Corporation
Primary completion
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation		 2.1 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03570255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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