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Methods for the Measurement of Respiratory Rate

23 de marzo de 2016 actualizado por: Niels Egholm Pedersen, Herlev Hospital

This study aims to investigate these research questions:

  1. Is there a difference in the results obtained, when respiratory rate is measured automatically by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with a research assistant using a criterion standard approach?
  2. Is there a difference in the results obtained, when respiratory rate is measured automatically by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with hospital staff's current clinical practice?

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Respiratory rate is among the first vital signs to change when a deterioration in patient conditions occurs, and that it is highly useful in identifying high-risk patients, patients in pain, risk of death in patients treated for myocardial infarctions and medical patients at risk of cardiac arrest.

Respiratory rate is one of the seven physiological parameters included in the Early Warning Score (EWS), an aggregated track- and trigger-system for risk-stratification of patients in hospital wards at risk of imminent clinical deterioration. EWS includes an escalation protocol, defining when it is necessary for the ward staff to call for assistance and when vital parameters should be measured again.

Manual measurement of respiratory rates is the standard in hospital wards in the Capital Region of Denmark. During the measurement of respiratory rate, patients ideally have to lie still and refrain from talking. This poses a difficulty in daily, clinical practice. Several studies in hospital wards both using and not using an EWS-system report that respiratory rate is often omitted when vital signs are measured.

Even if the respiratory rate is measured regularly, poor inter-observer agreement and reproducibility of measured respiratory rates have been found. Respiratory rates recorded by nurses have been reported to be generally higher than those measured by observers using a standardised approach.

The EWS currently in use is validated using measurements obtained by normal nursing practise. If there is an element of human influence on the measurement of respiratory rate, automation could affect the prognostic properties of EWS in an unpredictable way, even if the automatically measured respiratory rates more reliably reflect the patients' physiology than current clinical practise.

If a systematic difference between the recordings by staff and the electronic devices currently on the market exists, this could have an implication on the EWS scores and subsequently, escalation protocols for patients with elevated EWS could be affected. If this is the case, EWS might even have to be re-validated using machine-measured respiratory rates.

Thus, even as there could be a number of advantages of automating the measurements of respiratory rates in hospital wards, due considerations are required before ward staff's manual measurement of respiratory rate can be replaced by measurements obtained from electronic devices. The purpose of this study is to evaluate if there is a systematic difference in the respiratory rate measurements performed by an electronic device (SensiumVitals® system, Sensium Healthcare) compared with the measurements performed by a research assistant using a criterion standard approach and the ward staff's usual measurements.

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Herlev, Dinamarca, 2730
        • Copenhagen Academy for Medical Education and Simulation and Medical-Short Time Ward, Herlev Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 18 years or older.
  • Able and willing to give informed consent to participation in the study and necessary data collection.
  • Admitted to the general medical short-time ward and planned stay there at the time of inclusion greater than two hours.

Exclusion Criteria:

  • Wounds, burns or other conditions that prevent proper attachment of the measurement device, or where wearing the device might cause or increase discomfort from wearing the device.
  • Allergies to medical graded tape or ECG electrodes.
  • Patients with cardiac pacemaker or implanted defibrillator.
  • Any condition or situation preventing proper information, consent and enrolment.
  • Respiratory rate measurements by another device using impedance pneumography.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Included patients
All included patients will have respiratory rates measured by a research assistant using a criterion standard approach, by the SensiumVitals device and by the ward staff.
The patients will have their respiratory rates, heart rates and temperature (axilla) measured continuously by the SensiumVitals patch.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in respiratory rate recorded by the research assistant using a criterion standard approach and the SensiumVitals device
Periodo de tiempo: 24 Hours
After enrolment at the general, medical short-time ward a research assistant will measure the patient's respiratory rate using a criterion standard approach. The time of this measurement will be registered, and the corresponding measurement made by the SensiumVitals device will be extracted and used for the comparison. Reported with Bland-Altman plots.
24 Hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in respiratory rate recorded by the ward staff using standard clinical practice and the SensiumVitals device
Periodo de tiempo: 24 Hours
The ward staff's first measurement of respiratory rate after the patient is enrolled in the study at the general, medical short-time ward as registered in the electronic patient journal. The time of this measurement will be registered, and the corresponding measurement made by the SensiumVitals device will be extracted and used for the comparison. Reported with Bland-Altman plots.
24 Hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Early Warning Score recorded by the research assistant
Periodo de tiempo: 24 Hours
Early Warning Score (point score) will be recorded using standard practice by the research assistant. Parameters included in the Early Warning Score: Peripheal arterial oxygen satuation (%), pulse (beats per minute), use of supplementary oxygen (liters per minute), systolic and diastolic blood pressure (mmHg), level of consciousness (AVPU-scale), temperature (degrees celcius) and pulse regularity (yes/no).
24 Hours
Early Warning Score recorded by the ward staff
Periodo de tiempo: 24 Hours
Early Warning Score (point score) recorded using standard practice by the ward staff. Early Warning Score consists of: Peripheal arterial oxygen satuation (%), pulse (beats per minute), use of supplementary oxygen (liters per minute), systolic and diastolic blood pressure (mmHg), level of consciousness (AVPU-scale) and temperature (degrees celcius).
24 Hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Niels E Pedersen, MD, Copenhagen Academy for Medical Education and Simulation, Herlev Hospital, Center for HR, Capital Region of Denmark

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2016

Finalización primaria (Actual)

1 de febrero de 2016

Finalización del estudio (Actual)

1 de febrero de 2016

Fechas de registro del estudio

Enviado por primera vez

11 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

29 de enero de 2016

Publicado por primera vez (Estimar)

3 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de marzo de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

23 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CAMES-16-001

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre SensiumVitals

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