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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657733
• Other study ID #: 10144939
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2015
• Last updated: November 1, 2016
• Start date: July 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Israel	Herzog Hospital	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Oridion	Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	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.	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	No