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Continuous Monitoring on the General Ward

24 de abril de 2017 actualizado por: Radboud University Medical Center

Continuous Monitoring of Vital Signs in Hospitalized Patients

Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.

Objective: to investigate the feasibility of wearable devices on the general ward.

Study design: feasibility study.

Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.

Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.

Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

90

Fase

  • No aplica

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 a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patient is 18 years or older on the day the informed consent will be signed.
  • Patient is hospitalized on the surgical or internal medicine ward.
  • MEWS measurements are required at least three times a day.
  • Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria:

  • Frequency of MEWS measurements is less than three times a day.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
Experimental: HealthPatch (Intervention)
Patients with HealthPatch and regular MEWS measurements
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
Experimental: ViSi Mobile (Intervention)
Patients with ViSi Mobile and regular MEWS measurements
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Expectations & experiences of patients
Periodo de tiempo: 2-3 days after informed consent
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
2-3 days after informed consent
Expectations & experiences of care givers
Periodo de tiempo: 1 year
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MEWS scores based on continuous data and data measured by nurses
Periodo de tiempo: 3 times a day, up to three days.
3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
Periodo de tiempo: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Periodo de tiempo: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
Periodo de tiempo: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
Periodo de tiempo: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
Periodo de tiempo: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
Periodo de tiempo: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Adverse events caused by devices
Periodo de tiempo: during 2-3 days when the patient wears a device
E.g. Itch or redness
during 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
Periodo de tiempo: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
Periodo de tiempo: Once a day during the 2-3 days the patient participantes in this study
Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
Periodo de tiempo: On day 2 or 3 when patients participates in the study
On day 2 or 3 when patients participates in the study
System usability Scale
Periodo de tiempo: 1 year
1 year

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Gender
Periodo de tiempo: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Age
Periodo de tiempo: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Diagnosis
Periodo de tiempo: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Performed surgical procedure
Periodo de tiempo: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

1 de abril de 2015

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

25 de julio de 2016

Primero enviado que cumplió con los criterios de control de calidad

13 de octubre de 2016

Publicado por primera vez (Estimar)

14 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de abril de 2017

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

24 de abril de 2017

Última verificación

1 de julio de 2016

Más información

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. .

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