Feasibility and Performance Evaluation of INVSENSOR00024

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2019-05-28

Brief Summary

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This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.

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Detailed Description

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Conditions

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Evaluation of SpO2 Performance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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RD SET Neo SpO2

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

Group Type EXPERIMENTAL

RD SET Neo SpO2

Intervention Type DEVICE

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

Interventions

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RD SET Neo SpO2

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to 1 month (28 days) of age
* Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent.
* Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria

* Subjects with both significant abnormal aortic arch and radial line in place
* Subjects with suspected or diagnosed critical congenital heart disease (CCHD)
* 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, severe edema, and other at the discretion of the Principal Investigator

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes