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Clinical Trials/NCT02657720
NCT02657720
Completed
Phase 4

Comparison Between Different Technologies That Measure Respiratory Rate

Oridion1 site in 1 country29 target enrollmentJuly 2015
ConditionsHealthy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Healthy
Sponsor
Oridion
Enrollment
29
Locations
1
Primary Endpoint
The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the 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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
August 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Oridion
Responsible Party
Sponsor

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.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.

Time Frame: six months

Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: breaths per 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 the reference device.(six months)

Study Sites (1)

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