Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)

November 1, 2016 updated by: Oridion
Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases. Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients. The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91035
        • Herzog Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Without Clinical diagnosis of heart disease.

Exclusion Criteria:

  • Want to be excluded
  • Breathing difficulties
  • Unabling or unwilling to follow the protocol.
  • Contact allergy to the adhesive neck sensor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers
Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System
Device: Radical-7

Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time.

Radical-7- measures respiratory rate according to acoustic respiratory rate (RRa).

Device: Nellcor™ Bedside Respiratory Patient Monitoring System

Comparison between 3 different monitors that measure repiratory rate. The participant is connected to 3 monitors at the same time.

Nellcor™ Bedside Respiratory Patient Monitoring System - measures respiratory rate according to oximetry respiration rate (RRoxi).

Device: Capnostream 20p
Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream 20p- measures respiratory rate according to Capnography (RRetco2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of different breathing rates (normal breathing, tachypnea, and bradypnea) on the accuracy of respiratory rate in breaths per minute as measured by the tested devices compared to a reference device.
Time Frame: 6 hours
Respiratory rate will be measured with the monitors (Radical-7 device, Nellcor device, Capnostream20p device) and recorded in the following units: Breath/minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device was accurate will be analyzed offline.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of hearing or performing noises on the accuracy of respiratory rates (in breaths per minute) as measured by the tested devices compared to a reference device.
Time Frame: 6 months
Respiratory rate will be measured with the monitors (Radical-7 device ,Nellcor device, Capnostream20p device) in breaths per minute. Differences in accuracy as compared to the reference device and differences in percentage of time in which the device indicated respiratory rate values will be analyzed offline.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oridion

Collaborators

Herzog Hospital

Investigators

  • Principal Investigator: Michal Eisenberg, MD, Herzog Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10144939

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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