INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2019-02-25

Brief Summary

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This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.

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Detailed Description

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Conditions

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Healthy

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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INVSENSOR00032 and INVSENSOR00033 test group

All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

Group Type EXPERIMENTAL

INVSENSOR00032 and INVSENSOR00033

Intervention Type DEVICE

Investigational pulse oximeter device

Interventions

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INVSENSOR00032 and INVSENSOR00033

Investigational pulse oximeter device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential.

Exclusion Criteria

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes