Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-02

Study Completion Date

2015-10-29

Brief Summary

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The purpose of this study was to conduct a side by side comparison of the accuracy of respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled conditions.

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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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Test group

The subjects will be enrolled in the test group and will simultaneously receive both RAM sensors.

Group Type EXPERIMENTAL

RAM sensors

Intervention Type DEVICE

Noninvasive acoustic monitoring device

Interventions

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RAM sensors

Noninvasive acoustic monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed written informed consent

Exclusion Criteria

* ASA physical status of III, IV, and V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participating in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes