INVSENSOR00013 Respiratory Rate Clinical Performance Study

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

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2018-02-14

Brief Summary

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The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.

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Signs and Symptoms, Respiratory

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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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INVSENSOR00013 Test group

All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.

Group Type EXPERIMENTAL

INVSENSOR00013

Intervention Type DEVICE

Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device

Interventions

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INVSENSOR00013

Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 to 70 years old
* 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 judgement of the investigator, renders them inappropriate for participation in the 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
* Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
* 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