Convenience Sample Data Collection for INVSENSOR00045

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2023-05-21

Brief Summary

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This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.

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Detailed Description

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Conditions

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Oxygen Saturation

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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INVSENSOR00045

All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.

Group Type EXPERIMENTAL

INVSENSOR00045

Intervention Type DEVICE

Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.

Interventions

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INVSENSOR00045

Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to 1 month of age
* Gestational age greater than 23 weeks
* Weight less than or equal to 5 kg
* Subjects with standard of care 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
* Subjects with axillary arterial lines
* Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes