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Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting

5 de noviembre de 2026 actualizado por: Gozde Altun, Istanbul University - Cerrahpasa

Preoperative Gastric Ultrasound Assessment and Anaesthetic Management in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting: A Multicentre Prospective Observational Study

Fasting before surgery does not always ensure that the stomach is empty. Residual gastric contents may be relevant to the risk of stomach contents entering the lungs during anaesthesia.

This multicentre prospective observational study will enrol 240 adults scheduled for elective isolated coronary artery bypass grafting at two hospitals in Türkiye. Gastric ultrasound will be performed before any sedative or anaesthetic medication is administered. The study will determine the proportion of patients with high-risk gastric contents despite routine preoperative fasting.

High-risk gastric contents will be defined as any solid or thick contents, or an estimated clear fluid volume greater than 1.5 mL/kg. Associations with patient characteristics, medical conditions, medication use and fasting duration will also be examined.

The anaesthetist's management plan will be recorded before the ultrasound findings are known. After the findings are communicated, any changes in surgical timing, anaesthetic induction, airway management or aspiration precautions will be documented. Fasting practices will not be modified for research purposes, and all clinical decisions will remain with the attending anaesthetist.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

An additional secondary objective is to identify preoperative factors associated with high-risk gastric contents detected by gastric ultrasound. High-risk gastric contents will be defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg, consistent with the primary outcome definition. Candidate variables will include age, sex, body mass index, diabetes mellitus and its duration, insulin use, chronic kidney disease, gastro-oesophageal reflux disease, hypothyroidism, preoperative laboratory values and medication use specified in the study protocol, and actual solid food and clear fluid fasting durations. These data will be obtained from participant interviews and preoperative medical records. Associations will be evaluated using logistic regression and reported as odds ratios with 95% confidence intervals, where estimable. Multivariable analysis will be performed if the number of participants with high-risk gastric contents permits, with the number of included variables restricted to reduce the risk of model overfitting.

Tipo de estudio

De observación

Inscripción (Estimado)

240

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.

Estudio Contacto

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye)
        • Istanbul University-Cerrahpasa Institute of Cardiology

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

Método de muestreo

Muestra no probabilística

Población de estudio

Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at Istanbul University-Cerrahpasa Institute of Cardiology and Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Türkiye. Patients prepared according to routine institutional preoperative fasting practices will be assessed consecutively during the recruitment period. Eligible patients who provide written informed consent will be enrolled.

Descripción

Inclusion Criteria:

  • Age 18 years or older.
  • Scheduled for elective isolated coronary artery bypass grafting.
  • Prepared according to routine institutional preoperative fasting practices.
  • Provision of written informed consent.

Exclusion Criteria:

  • Scheduled for emergency or urgent coronary artery bypass grafting.
  • Planned concomitant cardiac surgical procedure.
  • Body mass index of 40 kg/m² or greater.
  • Previous gastric or oesophageal surgery resulting in substantially altered gastric anatomy.
  • Gastric outlet obstruction or known mechanical gastrointestinal obstruction.
  • Inability to perform gastric ultrasound or obtain reliable measurements because of technically inadequate imaging.

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

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Patients Scheduled for Elective Isolated CABG

Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at two participating centres, prepared according to routine institutional fasting practices. Participants will undergo preoperative gastric ultrasound before receiving any sedative or anaesthetic medication. Gastric contents and the anaesthetic management plans before and after disclosure of ultrasound findings will be recorded prospectively. All clinical decisions will remain at the discretion of the attending anaesthetist.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants With High-Risk Gastric Contents on Preoperative Gastric Ultrasound
Periodo de tiempo: During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.

Percentage of participants with high-risk gastric contents, defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg. Clear fluid volume will be estimated using the Perlas model based on the mean of three gastric antral cross-sectional area measurements obtained in the right lateral decubitus position. An empty stomach or clear fluid volume of 1.5 mL/kg or less without solid or thick contents will be classified as low risk. Perlas grade 2 alone will not define high-risk gastric contents.

During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants With a Change in Planned Anaesthetic Management or Surgical Timing After Disclosure of Gastric Ultrasound Findings
Periodo de tiempo: On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.

Percentage of participants with a change in surgical timing, planned anaesthetic induction technique, planned intubation approach or device, or planned aspiration precautions. The management plan recorded before gastric ultrasound will be compared with the decision and revised plan recorded immediately after the findings are disclosed to the attending anaesthetist.

On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.
Proportion of Participants With a Management Change Directly Attributed to Gastric Ultrasound Findings
Periodo de tiempo: Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.

Percentage of all evaluated participants whose attending anaesthetist identifies the gastric ultrasound findings as the direct reason for a change in planned anaesthetic management or surgical timing. The type of change and the clinician-reported reason will be recorded.

Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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 (Estimado)

30 de noviembre de 2026

Finalización primaria (Estimado)

10 de mayo de 2027

Finalización del estudio (Estimado)

10 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 019

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is currently no plan to share individual participant data.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .