Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department (EDDRAPro)
Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The secondary objectives of this study are:
A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours.
B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated.
C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated.
E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated.
G-analyze patient outcomes by subgroup according to diagnosis (decompensated COPD, OAP, lung disease, asthma, pleural disease).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Nîmes Cedex 09, Francia, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Perpignan, Francia, 66046
- CH de Perpignan - Hôpital Saint Jean
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
- Patient affiliated with or beneficiary of a health insurance plan
- Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
- Breathing spontaneously (no ventilation)
Exclusion Criteria:
- Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
- Patient under judicial protection or any kind of guardianship
- Refusal to sign the consent
- Patient pregnant, parturient, or lactating
- Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
- Patient who received mechanical ventilation at home
- Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
- Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
- Patient suffering from a pneumothorax
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Prognostic study population
The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Intervention: Diaphragmatic ultrasound |
Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion. The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of diaphragmatic excursion by M-mode ultrasound
Periodo de tiempo: Day 0, baseline
|
in centimeters
|
Day 0, baseline
|
|
Use of ventilation within the first 4 hours
Periodo de tiempo: Day 0, baseline + 4 hours
|
yes/no
|
Day 0, baseline + 4 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of diaphragmatic excursion by M-mode ultrasound
Periodo de tiempo: Day 0, baseline + 4 hours
|
in centimeters
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Day 0, baseline + 4 hours
|
|
Acute respiratory distress signs within the first 4 hours
Periodo de tiempo: Day 0, baseline + 4 hours
|
yes/no
|
Day 0, baseline + 4 hours
|
|
Signs of respiratory re aggravation at 24 hours
Periodo de tiempo: Day 1
|
yes/no
|
Day 1
|
|
Diagnosis
Periodo de tiempo: Day 1
|
qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology
|
Day 1
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Enfermedades pulmonares
- Atributos de la enfermedad
- Infantil, Recién Nacido, Enfermedades
- Lesión pulmonar
- Infantil, Prematuro, Enfermedades
- Emergencias
- Síndrome de Dificultad Respiratoria
- Síndrome de Dificultad Respiratoria, Recién Nacido
- Lesión pulmonar aguda
Otros números de identificación del estudio
- LOCAL/20143/XBAC-01
- 2014-A00511-46 (Otro identificador: RCB number)
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