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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Device: Radical-7; Device: Nellcor™ Bedside Respiratory Patient Monitoring System; Device: Capnostream 20p

• Registration Number: NCT02657733
• Lead Sponsor: Oridion

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Nellcor™ Bedside Respiratory Patient Monitoring System	Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System
Healthy volunteers	Radical-7	Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System
Healthy volunteers	Capnostream 20p	Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Herzog Hospital; 🇮🇱 Jerusalem, Israel