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A Single Center Study Validating Accuracy of a Continuous Respiratory Rate Measurement Derived From a Respiratory Rate Monitoring Device (RRM): A Comparison With Capnography

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Qué se está evaluando

Respiration rate monitor

Dispositivo
Quiénes están siendo reclutados

A partir de 18 años
+8 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio Diagnóstico

Intervencional
Inicio del estudio: noviembre de 2021
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Resumen

Patrocinador PrincipalUniversity of Calgary
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 17 de noviembre de 2021

Fecha en la que se inscribió al primer participante.

While respiratory rate is considered a critical vital sign, it often goes unmeasured or is ignored primarily due to shortcomings of the currently used measurement methods. Respiratory rate provides important information on a person's health condition and physiological stability, and an abnormal respiratory rate is a strong indicator that a health crisis is imminent. In fact, a sudden change in respiratory rate is one of the strongest predictors of mortality. Current techniques of monitoring respiratory rate have drawbacks that limit the frequency and convenience of the respiratory monitoring. Recognizing that closer respiration monitoring can save lives and improve quality of life, reduce hospital stays, and lower medical costs, the health care industry is seeking improved respiration monitoring products. The allocation of high-risk patients to intensive care for more careful monitoring or after surgery is often arbitrary, and such care might not be available routinely. For those patients who are cared for in 'general' wards where staffing levels are limited, a practical continuous monitor of respiratory rate would be of great value. This study will act as a pilot to determine the feasibility of using respiratory sensor device to monitor respiratory rate in hospitalized patients. Deriving a measurement of respiratory rate from a respiratory rate monitoring (RRM) device is a technological approach that may overcome these limitations. The device principle is based on a piezoelectric sensor where chest expansions and contractions generate very small amounts of current by the piezoelectric sensor. The expansion and contractions are measured very accurately by over-sampling, filtering and digital signal processing to remove noise and any bias generated by the piezoelectric sensor itself or the sampling circuitry. The study will be conducted from March 2021 to September 2021. During the first phase a convenience sample of 30 patients undergoing general anesthesia with muscle paralysis and mechanical ventilation will be recruited. This phase will help to validate the RRM against capnography in mechanically ventilated patients with a set respiratory rate. Following the first phase, 120 patients undergoing a procedure using sedation or spinal anesthesia will be recruited. Patients will be breathing spontaneously, and the respiratory rate will be monitored by capnography connected to the face mask or nasal prongs. Respiratory rate detected by capnography is recorded in the electronic medical records on a minute to minute interval.

Título OficialA Single Center Study Validating Accuracy of a Continuous Respiratory Rate Measurement Derived From a Respiratory Rate Monitoring Device (RRM): A Comparison With Capnography
NCT04712240
Patrocinador PrincipalUniversity of Calgary
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 169 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio Diagnóstico

Los estudios diagnósticos se centran en mejorar como se detecta o confirma una enfermedad. Prueban nuevas herramientas o técnicas que podrían ofrecer diagnósticos más rápidos o precisos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

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Criterios

2 criterios de inclusión requeridos para participar
Adult participants >= 18 years of age scheduled for elective surgery

American Society of Anesthesiologists' Status Score <=3

6 criterios de exclusión impiden participar
Patients undergoing emergency surgery

Patients undergoing abdominal procedures requiring skin prep of the lower chest area

Patients undergoing breast surgery

Patients undergoing shoulder surgery

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Single group study whereupon participants will be fitted with portable respiration rate monitor around their chest for duration of surgery. Respiration rates acquired by the respiration rate monitor will be compared to capnography, which is standard of care and applied to all surgical cases

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

South Health Campus

Calgary, CanadaAbrir South Health Campus en Google Maps
Completado1 Centros de Estudio