- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07780981
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen including the esophagogastric junction. EndoFLIP has become an invaluable tool in pediatric gastroenterology helping to characterize various luminal conditions including but not limited to esophageal stenosis and compression, screening for dysmotility, guiding esophageal dilation through the selection of the optimal dilator size, among others. Despite its increasing clinical utility, there is currently no standardized protocol for its use and much of the technique is derived from adult practice.
Proceduralists perform measurements based on individual preference, with some favoring the supine position and others preferring the left lateral decubitus position. This lack of consensus has been an active topic of discussion among pediatric advanced endoscopists who perform EndoFLIP, yet no published studies exist comparing measurements obtained in different positions. This variability presents a significant clinical problem because positioning may influence EndoFLIP parameters through several physiological mechanisms. In the supine position, abdominal viscera shift posteriorly, potentially altering esophagogastric junction geometry and increasing intra-abdominal pressure. In the left lateral decubitus position, the gastric fundus falls away from the esophagogastric junction due to gravity, possibly reducing external compression and changing the angle of His. Additionally, diaphragmatic crural tension, thoracic mechanics, and vascular engorgement patterns may differ between positions, all of which could affect luminal measurements. These positional differences have important clinical implications, particularly when comparing preoperative and postoperative measurements, assessing dilation durability within the same procedure, or monitoring disease progression longitudinally over multiple visits. If measurements are obtained in different positions across these clinical scenarios, apparent changes in esophagogastric junction function may be artifactual rather than reflective of true physiological change.
The investigators hypothesize that patient positioning, supine versus left lateral decubitus, impacts EndoFLIP measurements. This is a non-directional hypothesis, as there is currently insufficient evidence to predict whether measurements will be higher or lower in one position compared to the other.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kenneth Ng, DO
- Número de teléfono: 410-955-8769
- Correo electrónico: kng13@jhmi.edu
Copia de seguridad de contactos de estudio
- Nombre: Ningfei Li, MD
- Número de teléfono: 4109556070
- Correo electrónico: nli56@jh.edu
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Reclutamiento
- Charlotte R. Bloomberg Children's Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- must be between 5 years and 21 years of age at the time of the procedure, which is within the FDA-approved age range for EndoFLIP use.
- participants must be scheduled to undergo a clinically indicated EndoFLIP procedure at Johns Hopkins Children's Center.
- participants must have a parent or legal guardian who is able to provide written informed consent in English, or with the assistance of translation services for non-English speakers.
- participants who are of appropriate age and developmental capacity must be able to provide assent for study participation.
- participants must be candidates for general anesthesia as determined by the anesthesia team.
Exclusion Criteria:
- patients younger than 5 years of age or 22 years of age and older will be excluded.
- patients who have contraindications to EndoFLIP will be excluded, including situations where upper endoscopy is generally contraindicated such as known or suspected gastrointestinal perforation, hemodynamic instability, severe coagulopathy, or inability to safely undergo general anesthesia.
- patients who cannot be safely positioned in both supine and left lateral decubitus positions due to medical or anatomical considerations will be excluded.
- pregnant patients will be excluded. Pregnancy status will be determined by patient or guardian report and, when clinically indicated, by urine or serum pregnancy testing per institutional protocols for patients of childbearing potential.
- patients whose parent or legal guardian declines to provide informed consent or patients who decline to provide assent when age-appropriate will be excluded.
- patients for whom the proceduralist or anesthesia team determines that participation in the research protocol would pose additional risk beyond routine clinical care will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Left lateral position first, supine position second
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The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen.
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Otro: supine position first, Left lateral position second
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The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diameter
Periodo de tiempo: During procedure only (less than 10 minutes)
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Diameter of esophagus (mm)
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During procedure only (less than 10 minutes)
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Cross sectional area
Periodo de tiempo: During procedure only (less than 10 minutes)
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Esophageal cross sectional area measured in square millimeters (mm²)
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During procedure only (less than 10 minutes)
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Compliance
Periodo de tiempo: During procedure only (less than 10 minutes)
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esophageal compliance (mm3/mmHg)
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During procedure only (less than 10 minutes)
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distensibility index
Periodo de tiempo: During procedure only (less than 10 minutes)
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esophageal distensibility index(mm2/mmHg)
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During procedure only (less than 10 minutes)
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Pressure
Periodo de tiempo: During procedure only (less than 10 minutes)
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intraluminal esophageal pressure (mmHg)
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During procedure only (less than 10 minutes)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Differences in diameter
Periodo de tiempo: During procedure only (less than 10 minutes)
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calculated difference in diameter between supine vs left lateral position (mm), percentage difference from left lateral position to supine position and also supine to left lateral position
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During procedure only (less than 10 minutes)
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Differences in Cross sectional area
Periodo de tiempo: During procedure only (less than 10 minutes)
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calculated difference in Cross sectional area between supine vs left lateral position (mm2), percentage difference from left lateral position to supine position and also supine to left lateral position
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During procedure only (less than 10 minutes)
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Differences in esophageal compliance (mm3/mmHg)
Periodo de tiempo: During procedure only (less than 10 minutes)
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calculated difference in esophageal compliance (mm3/mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
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During procedure only (less than 10 minutes)
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Differences in esophageal distensibility index(mm2/mmHg)
Periodo de tiempo: During procedure only (less than 10 minutes)
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calculated difference in esophageal distensibility index(mm2/mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
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During procedure only (less than 10 minutes)
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Differences in intraluminal esophageal pressure (mmHg)
Periodo de tiempo: During procedure only (less than 10 minutes)
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calculated difference in intraluminal esophageal pressure (mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
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During procedure only (less than 10 minutes)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kenneth Ng, DO, Johns Hopkins University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Eosinofilia
- Trastornos de los leucocitos
- Enfermedades hematológicas
- Enfermedades esofágicas
- Enfermedades de la piel
- Gastroenteritis
- Anomalías congénitas
- Enfermedades Otorrinolaringológicas
- Enfermedades De La Piel Genéticas
- Enfermedades faríngeas
- Anomalías de la piel
- Enfermedades De La Piel Vesiculoampollosa
- Esofagitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Comportamiento
- Enfermedades de la piel y del tejido conectivo
- Enfermedades hemic y linfáticas
- Comportamiento social
- Trastornos de la deglución
- Epidermólisis Bullosa
- Esofagitis eosinofílica
- Estenosis esofágica
- Acalasia esofágica
- Trastornos de la motilidad esofágica
- Engaño
Otros números de identificación del estudio
- IRB00560539
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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