- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07722897
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Erkan Göksu, MD
- Número de teléfono: +905054691764
- Correo electrónico: erkangoksu@akdeniz.edu.tr
Ubicaciones de estudio
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Antalya, Turquía (Türkiye), 07059
- Reclutamiento
- Akdeniz University Hospital
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Contacto:
- Erkan Göksu, MD
- Número de teléfono: 05054691764
- Correo electrónico: erkangoksu@akdeniz.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Adults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.
Patients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.
Patients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.
Written informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.
Exclusion Criteria:
Age <18 years. Cardiac arrest before or during induction. Patients requiring immediate ("crash") intubation without sufficient time for BIS monitoring.
Inability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).
Pregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Emergency Department Patients Undergoing Rapid Sequence Intubation
Adult patients undergoing rapid sequence intubation in the emergency department.
Bispectral index (BIS) monitoring is used to confirm adequate depth of anesthesia before laryngoscopy.
Hemodynamic parameters are recorded before, during, and after endotracheal intubation.
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Bispectral index monitoring is used to assess the depth of anesthesia before laryngoscopy.
Endotracheal intubation is performed after an adequate BIS value has been achieved.
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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 Diastolic Blood Pressure Following Rapid Sequence Intubation
Periodo de tiempo: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Diastolic Blood pressure (MAP) measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
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Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Change in Systolic Blood Pressure Following Rapid Sequence Intubation
Periodo de tiempo: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Systolic Blood pressure measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
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Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Change in Heart Rate Following Rapid Sequence Intubation
Periodo de tiempo: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Heart Rate measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
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Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
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Colaboradores e Investigadores
Patrocinador
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Finalización del estudio (Estimado)
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Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
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Otros números de identificación del estudio
- AkdenizUH1
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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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