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El ensayo clínico NCT06263595 para Aspiración pulmonar está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad de CalgarySemaglutide and Preoperative Residual Gastric Volumes 90
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06263595 es un estudio observacional para Aspiración pulmonar. Su estado actual es: reclutando. El estudio se inició el 31 de mayo de 2024, con el objetivo de reclutar a 90 participantes. Dirigido por la Universidad de Calgary, se espera que finalice el 31 de julio de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2025.
Resumen
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by rece...Mostrar más
Título oficial
Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
Condiciones médicas
Aspiración pulmonarOtros ID del estudio
- REB23-1754
Número del NCT
Inicio del estudio (real)
2024-05-31
Última actualización
2025-03-25
Fecha de finalización (estimada)
2025-07-31
Inscripción (prevista)
90
Tipo de estudio
Observacional
Estado general
Reclutando
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
GLP-1 Agonist Group Intervention: elective surgical patients taking GLP-1 receptor agonists | gastric antral sonography Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed. |
Non GLP-1 Agonist Group Intervention: elective surgical patients not taking GLP-1 receptor agonists | gastric antral sonography Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of participants presenting with a full stomach | Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography. | Measured in the preoperative holding area |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of occurrences requiring change in anesthetic management plan | Changes in plan include those from laryngeal mask airway to more advanced endotracheal tube with rapid sequence induction and intubation or spinal anesthetic without sedation to administration of a general anesthetic. | From time of preoperative ultrasound in holding area to anesthesia induction in operating room |
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume | Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume | Measured in the preoperative holding area |
Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration | Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management | Measured in the preoperative holding area |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- all elective surgical patients (> 18 years of age)
- followed institutional fasting protocol for surgery
- patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
- patients not taking GLP-1 receptor agonist (N =45)
- confounding delayed gastric emptying due to pregnancy
- previous esophageal or gastric operation
- etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
- on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
Universidad de Calgary215 estudios activos para explorarAlberta Health servicesParte responsable del estudio
Joanna Moser, Investigador principal, Clinical Assistant Professor, University of Calgary
Contactos centrales del estudio
Contacto: Joanna J Moser, MD, PhD, 403-956-3883, [email protected]
1 Centros del estudio en 1 países
Alberta
South Health Campus, Calgary, Alberta, T3M 1M4, Canada
Joanna J Moser, MD, PhD, Contacto, 403-956-3883, [email protected]
Reclutando