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OpenTrials
Completed

NCT Number: NCT02657720

Comparison Between Different Technologies That Measure Respiratory Rate

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herzog Hospital

Jerusalem, 91035, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical 7

Device

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).

Capnostream20p

Device

Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream20p measures respiratory rate using capnography (RRetCO2).

PTAF2

Device

Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. PTAF2 measures respiratory rate using flow pressure (RRflow).

Other names: Flowmeter

Primary outcomes

  1. 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

  1. 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.

    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 indicated respiratory rate values will be analyzed offline.

Sponsors and collaborators

Lead sponsor

Oridion

Industry

Collaborators

  • Herzog Hospital

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2016
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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