- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02861508
Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
27 de febrero de 2020 actualizado por: Yale University
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
170
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
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale New Haven Hospital
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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:
- Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1)
Exclusion Criteria:
- <18 years old
- Prisoner or ward of the state
- Trauma
- High acuity requiring treatment in resuscitation room
- Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
- Any form of "do not resuscitate" (DNR) order
- Roomed in hall of emergency department (location not amenable to ultrasound protocol)
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Usual care
Usual care as determined by treating team.
Ultrasound may still be part of the workup per the treating team's discretion.
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Experimental: Early POCUS
Point-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to appropriate intervention
Periodo de tiempo: Within 30 days of presentation
|
Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received.
Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected.
All these time points are readily available in the electronic medical record in the patient care timeline.
This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.
|
Within 30 days of presentation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Diagnostic accuracy
Periodo de tiempo: Within 30 days of presentation
|
The treating team in the ED will be asked for their diagnostic impression of the patient's chief complaint at several points during the patient's time in the ED.
These points will be (1) after the primary provider's initial assessment, (2) at time of disposition, and (3) if they are in the early POCUS group, after the POCUS findings are relayed to them.
They will select their single most likely diagnosis each time, which will be compared against a final diagnosis as determined by final review of the patient's overall visit in the medical record (as this study's gold standard for diagnosis).
This outcome will examine how often (percentage-wise) the treating team's diagnosis matches the final diagnosis as well as if early POCUS has any impact on helping physicians reach the correct diagnosis.
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Within 30 days of presentation
|
Diagnostic certainty
Periodo de tiempo: Within 2 days of presentation
|
Similar to the outcome of diagnostic accuracy, the treating team in the ED will concomitantly be asked how certain they feel about their diagnosis on a five-point scale.
The presence of any changes in certainty (i.e.
proportion of patients for whom certainty changed) as well as how much change (e.g.
increased certainty by 2 points) will be assessed.
This outcome will determine if early POCUS affects physicians' certainty of diagnosis.
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Within 2 days of presentation
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Time to disposition
Periodo de tiempo: Within 2 days of presentation
|
This will be measured as amount of time (in minutes) that elapse between the time patient is roomed in the ED to time the treating team determines patient disposition.
These timestamps are available in the medical record under the patient care timeline.
This outcome will examine if early POCUS affects the time it takes for the treatment team to achieve a disposition plan for the patient.
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Within 2 days of presentation
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Total length of stay
Periodo de tiempo: Within 30 days of presentation
|
This will be measured as time (in days) between the patient's date of presentation and date of discharge.
This outcome will examine if early POCUS affects the amount of time that patients stay in the hospital.
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Within 30 days of presentation
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30-day in-hospital mortality
Periodo de tiempo: Within 30 days of presentation
|
Patients will be followed in their medical record for up to 30 days after their initial presentation to assess for in-hospital mortality rate.
This outcome will examine if early POCUS leads to any significant difference in patient mortality rate compared to usual care.
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Within 30 days of presentation
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Duration of POCUS
Periodo de tiempo: Within 2 days of presentation
|
For the early POCUS group, this will be measured as the amount of time (in minutes) between the time the ultrasound is started and the time the last image is captured.
All images/video clips acquired by the ultrasound machine have a timestamp.
A blank image will be captured at the start of the exam for the initial timestamp.
This outcome will examine how time-consuming our POCUS exam is and provides a sense of how disruptive the introduction of POCUS might be if it were implemented routinely.
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Within 2 days of presentation
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Return visits with missed diagnosis
Periodo de tiempo: Within 30 days of presentation
|
The patient's medical record will be followed for 30 days after initial presentation for the presence of any repeat visits with the healthcare system for a similar chief complaint.
If so, that repeat visit will be reviewed for the presence of a different diagnosis than that established at the original visit, which would suggest that the correct diagnosis had been missed at that time.
It will then be determined what the percentage of patients is with such visits out of all patients in the study.
This outcome will examine if POCUS helps with picking up diagnoses that might be missed otherwise.
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Within 30 days of presentation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christopher Moore, MD, Yale University
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 julio de 2016
Finalización primaria (Actual)
30 de junio de 2018
Finalización del estudio (Actual)
30 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2016
Publicado por primera vez (Estimar)
10 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
27 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Dolor
- Manifestaciones neurológicas
- Manifestaciones neuroconductuales
- Atributos de la enfermedad
- Signos y Síntomas Respiratorios
- Inconsciencia
- Trastornos de la conciencia
- Emergencias
- Dolor de pecho
- Hipotensión
- Síncope
- Disnea
Otros números de identificación del estudio
- 1605017729
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
No specific plans for now but would be open to sharing anonymized data.
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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