Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
Descripción general del estudio
Estado
Descripción detallada
Percutaneous endoscopic gastrostomy is commonly used to provide long-term enteral nutrition in patients who are unable to maintain adequate oral intake. Elderly patients with severe systemic disease and high anesthetic risk may be vulnerable to sedation-related cardiopulmonary adverse events. In some clinical settings, PEG can be performed using topical pharyngeal anesthesia and local anesthesia without systemic sedation.
This study will prospectively include elderly ASA IV patients undergoing PEG placement in routine clinical practice. Patients will be categorized into two cohorts according to the sedation strategy used during the procedure: unsedated PEG and sedated PEG. The sedation strategy will not be assigned by the investigators and will be determined according to routine clinical assessment, patient condition, and anesthesiology evaluation when required.
The study will compare cardiopulmonary complications within 24 hours, technical success, procedure-related complications, and 30-day clinical outcomes between the two cohorts.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mahsum Barçın, MD
- Número de teléfono: +9005448895064
- Correo electrónico: dr.mahsumbarcin@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with indications for percutaneous endoscopic gastrostomy for long-term enteral nutrition.
- Patients who have provided written informed consent from the patient or their legally authorized representative.
- Those with an Anesthesia Score of ASA 4.
Exclusion Criteria:
- Need for emergency PEG placement;
- International normalized ratio (INR) greater than 1.5;
- Platelet count less than 50,000/mm³;
- Severe ascites,
- Active peritonitis; pregnancy;
- Refusal to participate in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Unsedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.
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Sedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice.
Sedative agents may include propofol, midazolam, and/or opioid agents according to clinical and anesthesiology evaluation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of cardiopulmonary complications within 24 hours after PEG placement
Periodo de tiempo: Within 24 hours after PEG placement
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Cardiopulmonary complications will be assessed as a composite outcome including the occurrence of at least one of the following events within the first 24 hours after PEG placement: hypoxemia defined as SpO₂ <90%, hypotension defined as mean arterial pressure <65 mmHg, bradycardia defined as heart rate <50 beats/min, aspiration, need for endotracheal intubation, or intensive care unit admission/transfer.
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Within 24 hours after PEG placement
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Hilmi Bozkurt, MD,PhD, Mersin 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
Otros números de identificación del estudio
- PEG study 2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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