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TELERESPValidation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

healthy volonteers

+ Free breath monitoring

+ healthy volonteers

Dispositivo
Quiénes están siendo reclutados

Enfermedades del sistema nervioso+2

+ Trastornos de la respiración

+ Enfermedades del Tracto Respiratorio

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio Diagnóstico

Intervencional
Inicio del estudio: noviembre de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalCentre d'Investigation Clinique et Technologique 805
Última actualización: 26 de septiembre de 2014
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de noviembre de 2012

Fecha en la que se inscribió al primer participante.

Context: Mechanical ventilation transformed the prognosis of neuromuscular diseases whether for acute or chronic diseases. The available tools to estimate the severity of respiratory insufficiency and indicate or follow the efficiency of mechanical ventilation are based on blood gazes explorations, tests respiratory function and sleep evaluation. These tools give either limited information, or are with difficulty applicable to patients heavily handicapped except during hospitalization. In patients under mechanical ventilation, it is sometimes difficult to know the daily optimal time of ventilation. The respiratory events are not generally recognized and are unspecific (headaches, drowsiness, dyspnoea, etc.) or are identified by blood gazes abnormalities (hypercapnia. In acute setting, treble is going to raise the problem of the weaning of the mechanical ventilation and the optimal moment of the extubation without risking a reintubation. These problems are identical and concern the evaluation of the degree of ventilatory autonomy for home care. The development of methods estimating this autonomy is thus fundamental. Objectives: the objective of this project is to validate a non-invasive system for measure and acquisition of respiratory parameters, incorporating a transmission system working by a "wireless" technology allowing the remote monitoring of these patients. The secondary objectives are to determine the parameters of success of weaning by using the device in neuromuscular patients intubated for respiratory failure in acute setting and to determine the optimal time of free breathing possibilities in patients ventilated in a chronic way at home. Methods: After validation of the device on 10 healthy subjects, continuous acquisition of the ventilatory data by means of the Teleresp system compared with measure of the transcutaneous PCO2, of SaO2 and arterial gazometry at the end of free breath trial in 40 acute and chronic neuromuscular patients. Selection criteria: Healthy volunteers Patients affected by acute neuromuscular pathology and starting weaning from invasive ventilation (Guillain Barré and myasthenia). Patients affected by neuromuscular pathology and home ventilated in a diurnal and night-way by invasive interface or not (respiratory autonomy of at least 1:00 am). Number of patients, center: 10 healthy volunteers and 40 patients hospitalized in the intensive care unit or in the home of ventilation unit of the Raymond Poincaré hospital. Total duration of the study: 19 months

Patrocinador PrincipalCentre d'Investigation Clinique et Technologique 805
Última actualización: 26 de septiembre de 2014
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 10 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.
Condiciones
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 permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades del sistema nerviosoTrastornos de la respiraciónEnfermedades del Tracto RespiratorioEnfermedades NeuromuscularesInsuficiencia Respiratoria

Criterios

Inclusion Criteria: Healthy volonteers Man or woman of more than 18 years Realization of a preliminary medical examination Patient having signed an informed and written consent Major healthy subjects, presenting no chronic pathology or not chronic patients Chronic patients Man or woman of more than 18 years Affected by neuromuscular pathology Realization of a preliminary medical examination Patient in the stable state at the time of the study for at least 1 month Ventilated in a not invasive or invasive way in diurnal and night-period. Respiratory autonomy > 1:00 am Patient having signed an informed and written consent Acute Patients Man or woman of more than 18 years Affected by syndrome of Guillain blocked in aigue phase having required the invasive ventilation or affected by myasthenia generalized with myasthénique crisis having required the invasive ventilation. Realization of a preliminary medical examination Patient in phase of neurological recovery Vital Capacity > 15 ml / kg Respiratory Autonomy > 1:00 am Patient having signed a lit(enlightened) and written consent Exclusion Criteria: Healthy volonteers subject refusing to participate in the study subject under guardianship or guardianship Pregnant or breast-feeding Woman Chronic patients Patient refusing to participate in the study Patient under guardianship or guardianship Pregnant or breast-feeding Woman Patients ventilated only at night Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy Acute patients Patient refusing to participate in the study Patient or subject under guardianship or guardianship Pregnant or breast-feeding Woman Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy FIO2 > 40 % PEP > 5 cms H2O State of shock

Plan de Estudio

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

3 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Free breath monitoring. Correlation between two device for recording parameters of ventilation.

Grupo II

Experimental
Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2)

Grupo III

Experimental
Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2)

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Hopital Raymond Poincare

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Suspendido1 Centros de Estudio