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Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying (GLP-1) 50 No invasivo Observacional

Aún no recluta
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 NCT06659159 (GLP-1) es un estudio observacional para Pulmonary Aspiration During Anaesthetic Induction. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de noviembre de 2024 hasta completar 50 participantes. Dirigido por Sascha Battig, se espera que finalice el 31 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 26 de octubre de 2024.
Resumen
This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surge...Mostrar más
Descripción detallada
This project investigates the risk of pulmonary aspiration during anesthesia in patients undergoing treatment with GLP-1 agonists, a class of medications that prolong gastric emptying and are commonly used for obesity and diabetes management. Pulmonary aspiration remains a significant cause of morbidity and mortality in anesthesia-related complications, and patients with delayed gastric emptying are at higher risk. R...Mostrar más
Título oficial

Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying: a Prospective Ultrasound Approach with Focus on Perioperative Aspiration Risk.

Condiciones médicas
Pulmonary Aspiration During Anaesthetic Induction
Otros ID del estudio
  • GLP-1
  • Effects of beginning a GLP1
  • Hirslanden Klinik (Otra financiación) (Hirslanden Klinik, Zurich)
Número del NCT
NCT06659159
Inicio del estudio (real)
2024-11-01
Última actualización
2024-10-26
Fecha de finalización (estimada)
2026-12-31
Inscripción (prevista)
50
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
Pulmonary aspiration
Gastric ultrasound
GLP-1
Gastroparesis
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
GLP-1, New Therapy
Indication, prescription and dosage is determined independently of the study by the endocrinologist/obesity specialist, who is also part of the study team. Since the first gastric ultrasound will take place directly before the initiation of the GLP-1 Agonist therapy, the patients will serve as their own control group/baseline.
Ultrasonido gástrico
The sequence in which the study is conducted will be as follows, the first examination (baseline examination) will take place immediately before the appointment and prescription of GLP-1 Analoga (before the first injection). During the examination the gastric content (quality/quantity) will be determined, secondly, a baseline for gastric emptying time after oral intake of 500ml of water is collected (patient drinks w...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Gastric content
Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Gastric emptying time
Sonographic measurement of gastric emptying time for 500ml of water before and during GLP-1 therapy. Gastric emptying time is measured with a continuous ultrasound examination. The variable of interest is once again the CSA of the gastric antrum and the time until the baseline from before water consumption is reached once again.
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Number of empty stomachs
Absolute number of empty stomachs after adhering to standardised perioperative fasting intervals (6 hours for solids and 2 hours for liquids) before and once (if therapy is continued: twice) during GLP-1 Agonist therapy
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
BMI
Demographic data of the patient: BMI
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Gallbladder stones
Presence of gallbladder stones (cholecystolithiasis)
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Co-morbidities
Demographic data of the patients: Comorbidities
At the baseline examination at the first endocrinologic appointment
Side effects GLP-1
Collection of all side-effects of the GLP-1 therapy
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Discontinuation GLP-1
Number and reason for discontiuation of GLP-1 therapy
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Co-medication
For gastric emptying relevant co-medications
baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
  • Signed informed consent

  • Known pregnancy, known lactation
  • Underage (< 18 years)
  • Absence of informed consent (missing or inability to provide)
  • Anomalies of the gastrointestinal tract
  • Known illnesses of the gastrointestinal tract
  • Previous surgery of the gastrointestinal tract
  • Elevated risk for hypoglycaemia (Sulfonylurea or Insulin)
  • No investigator with completed structural education in gastric sonography is available
  • Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination
Sascha Battig logoSascha Battig
Parte responsable del estudio
Sascha Battig, Investigador-patrocinador, Prof. Dr. med. Michael Ganter, Klinik Hirslanden, Zurich
Contactos centrales del estudio
Contacto: Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med., +41 44 387 38 80, [email protected]
Sitio no especificado.