- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07810907
Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
Effect of Resuscitation on Gastric Emptying by Gastric Residual Volume Assessment Using Point of Care Ultrasonography in Pediatric Trauma Patients
Pediatric trauma often leads to hemorrhagic shock, which reduces blood flow to the digestive tract and delays gastric emptying. This delay can cause fluid and food to remain in the stomach, increasing the risk of pulmonary aspiration during urgent airway management or emergency anesthesia. Point-of-care ultrasound (POCUS) is a bedside, non-invasive tool that allows clinicians to evaluate stomach contents and estimate gastric volume in real time.
The primary purpose of this study is to evaluate whether restoring systemic blood flow through hemodynamic resuscitation improves gastric emptying and decreases gastric residual volume in injured children.
Participants aged 2 to 7 years presenting to the emergency department with trauma and hemorrhagic shock will receive standard resuscitation according to pediatric advanced life support guidelines. Bedside gastric ultrasound will be performed to measure the antral cross-sectional area and calculate gastric residual volume before resuscitation begins, immediately following initial resuscitation, and every 6 hours for up to 48 hours. Ultrasound procedures are observational and will not delay any standard trauma care or urgent surgical interventions.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
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Descripción
Inclusion Criteria:
- Pediatric patients aged 2 to 7 years presenting with trauma.
- Presenting with hemorrhagic shock requiring hemodynamic resuscitation (diagnosed according to Advanced Paediatric Life Support [APLS] guidelines based on clinical and laboratory evidence of inadequate tissue perfusion secondary to acute blood loss, such as age-adjusted hypotension, tachycardia, prolonged capillary refill time > 2 seconds, weak peripheral pulses, altered mental status, elevated serum lactate, and/or increased base deficit).
- Hemodynamically stable enough to undergo point-of-care gastric ultrasound (POCUS) examination without delaying emergency medical management.
Exclusion Criteria:
- Known gastrointestinal diseases affecting gastric motility (e.g., gastric outlet obstruction, intestinal obstruction).
- History of prior upper gastrointestinal surgery.
- Significant abdominal injury that may affect gastric motility.
- Need for immediate emergency surgical intervention before completion of study baseline assessments.
- Inability to adequately perform gastric POCUS (e.g., extensive abdominal wounds, surgical emphysema, or poor acoustic window).
- Gastric decompression performed before the initial ultrasound assessment.
- Isolated head injury.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Pediatric Trauma Resuscitation Cohort
Pediatric trauma patients aged 2 to 7 years presenting to the Emergency Department with hemorrhagic shock requiring hemodynamic resuscitation.
Participants undergo point-of-care gastric ultrasonography (POCUS) to assess gastric residual volume (GRV) and antral cross-sectional area (CSA) before resuscitation, immediately following successful hemodynamic resuscitation, and subsequently every 6 hours for up to 48 hours.
Resuscitation protocols, clinical parameters, and standard trauma care are administered according to institutional and Advanced Pediatric Life Support (APLS) guidelines without delay.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Gastric Residual Volume (GRV)
Periodo de tiempo: Baseline, Up to 4 Hours
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Change in gastric residual volume (mL/kg) from pre-resuscitation baseline to immediately after completion of hemodynamic resuscitation.
Antral cross-sectional area (CSA) will be measured by point-of-care gastric ultrasound (POCUS) in the right lateral decubitus position (CSA = AP × CC × π/4), and gastric volume will then be estimated using the Spencer formula and normalized to body weight (mL/kg).
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Baseline, Up to 4 Hours
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Colaboradores e Investigadores
Patrocinador
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Otros números de identificación del estudio
- Pediatric Trauma Gastric POCUS
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