NCT02657733

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Oridion · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2016-01-18
• Last updated: 2016-11-02

Locations

1 site across 1 country: Israel