Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department
Effect of Push-Dose Adrenaline on Peri-intubation Cardiovascular and Clinical Outcomes During Rapid Sequence Intubation in the Emergency Department: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.
This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rapid sequence intubation is a standard advanced airway procedure used in emergency departments for critically ill patients who require rapid and secure airway control. Although this procedure is clinically necessary, it may be associated with peri-intubation hypotension, commonly defined as systolic blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg during or after the intubation period. This hemodynamic deterioration may result from the patient's underlying critical illness, the cardiovascular effects of induction agents, reduced venous return after initiation of positive-pressure ventilation, or a combination of these factors.
Preventing hypotension during rapid sequence intubation is an important component of peri-intubation resuscitation. Intravenous fluids and vasopressor infusions are frequently used when hypotension develops, but these interventions may not always be fast enough to prevent early hemodynamic collapse. Push-dose vasopressors are used in emergency and critical care practice to provide short-term hemodynamic support. However, prospective randomized evidence regarding the preemptive use of push-dose adrenaline during emergency department rapid sequence intubation remains limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted in the emergency department of Marmara University Pendik Training and Research Hospital. Adult patients undergoing rapid sequence intubation, who are hypotensive or considered to be at significant risk of hypotension, will be enrolled after informed consent is obtained from the patient or legally authorized representative when applicable.
Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before the administration of induction agents. The intervention and placebo syringes will be identical in volume and appearance. Syringes will be prepared according to the randomization list by an independent non-blinded nurse who will not participate in clinical care, outcome assessment, or data collection. Treating physicians, participants, investigators, care providers, and outcome assessors will remain blinded to group allocation.
The decision to perform intubation, selection and dosing of induction and neuromuscular blocking agents, endotracheal tube size, and post-intubation management will be determined by the treating physician according to standard emergency department practice and current clinical guidance. Study procedures will not delay airway management or standard resuscitative care.
Hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, will be recorded at baseline and during the first 60 minutes after intubation. The study will evaluate peri-intubation hypotension, changes in mean arterial pressure, post-intubation vasopressor requirements, new ventricular or supraventricular arrhythmias, reactive hypertension, cardiac arrest, and mortality at predefined time points. The planned enrollment is 128 participants.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emre Kudu, MD
- Número de teléfono: +90 5067613610
- Correo electrónico: dr.emre.kudu@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Emir Ünal, MD
- Correo electrónico: emirunal@gmail.com
Ubicaciones de estudio
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Pendik
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Istanbul, Pendik, Turquía (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
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Contacto:
- Emre Kudu, MD
- Número de teléfono: +90 5067613610
- Correo electrónico: dr.emre.kudu@gmail.com
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Contacto:
- Emir Ünal, MD
- Correo electrónico: emirunal@gmail.com
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Investigador principal:
- Emre Kudu, MD
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Sub-Investigador:
- Emir Ünal, MD
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Sub-Investigador:
- Hasan Temel, MD
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Sub-Investigador:
- Erhan Altunbaş, MD
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Sub-Investigador:
- Sinan Karacabey, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation
- Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation
- Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity
Exclusion Criteria:
- Pregnancy
- Known allergy to adrenaline
- Known contraindication to adrenaline administration
- Withdrawal of consent by the patient or legally authorized representative after enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a 1 mL intravenous placebo bolus of 0.9% sodium chloride immediately before induction.
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Participants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation.
The placebo syringe is identical in volume and appearance to the adrenaline syringe.
Otros nombres:
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Comparador activo: Push dose adrenaline
Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a preemptive 10 mcg intravenous bolus dose of adrenaline immediately before induction.
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Participants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Peri-intubation hypotension
Periodo de tiempo: Within 60 minutes after intubation
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Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation.
The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.
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Within 60 minutes after intubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in mean arterial pressure from baseline
Periodo de tiempo: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
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Mean arterial pressure will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation.
Changes from baseline will be compared between the adrenaline and placebo groups.
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Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
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Change in heart rate from baseline
Periodo de tiempo: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
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Heart rate will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation.
Changes from baseline will be compared between the adrenaline and placebo groups.
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Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
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Post-intubation vasopressor requirement
Periodo de tiempo: 1 hour and 24 hours after intubation
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The need for continuous vasopressor infusion after intubation will be recorded.
Total vasopressor dose administered during the first hour and the first 24 hours after intubation will be compared between the adrenaline and placebo groups.
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1 hour and 24 hours after intubation
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Adverse events
Periodo de tiempo: Within 24 hours after intubation
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Adverse events including reactive hypertension, cardiac arrest, mortality
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Within 24 hours after intubation
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: Emre Kudu, MD, Marmara University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Atributos de la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Emergencias
- Químicos orgánicos
- Preparaciones farmacéuticas
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Amina
- Químicos inorgánicos
- Compuestos de cloro
- Catecols
- Fenoles
- Derivados de benceno
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Alcoholes
- Amino alcoholes
- Etanolaminas
- Monoaminas biogénicas
- Aminas biogénicas
- Catecolaminas
- Compuestos de sodio
- Cloruros
- Ácido clorhídrico
- Epinefrina
- Solución salina
- Cloruro de sodio
Otros números de identificación del estudio
- 09.2026.764
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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