Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Oridion
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)