Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
17 de julio de 2026 actualizado por: Samsun University
Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
This prospective observational study aims to compare the ventilation performance and safety of the i-gel and SaCoVLM supraglottic airway devices in adult patients undergoing elective laparoscopic cholecystectomy.
Ventilation-related parameters, airway sealing performance, insertion characteristics, and perioperative complications will be evaluated.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
Laparoscopic surgery requires the creation of pneumoperitoneum and frequently involves patient positioning changes, both of which can increase intrathoracic and airway pressures. These physiological changes may affect the performance of supraglottic airway devices and challenge effective ventilation.
Second-generation supraglottic airway devices are increasingly used as alternatives to endotracheal intubation in laparoscopic procedures because they provide effective ventilation while reducing airway-related complications. The i-gel is widely used due to its ease of insertion, integrated gastric drainage channel, and favorable safety profile. The SaCoVLM (Video Laryngeal Mask) is a novel supraglottic airway device that enables direct visualization of laryngeal structures during placement, allowing confirmation of optimal positioning and potentially improving airway management.
This prospective observational study will compare the i-gel and SaCoVLM in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Ventilation performance, airway sealing pressure, insertion success, ease of placement, hemodynamic responses, and perioperative airway-related complications will be assessed. The findings may provide further evidence regarding the clinical performance and safety of these devices during laparoscopic surgery.
Tipo de estudio
De observación
Inscripción (Estimado)
80
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
- Nombre: Hatice Selçuk Kuşderci
- Número de teléfono: 505 215 98 96
- Correo electrónico: drkusderci@hotmail.com
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will consist of adult patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia at Samsun City Hospital.
Eligible patients who provide written informed consent and meet the study inclusion criteria will be consecutively enrolled during the study period.
Descripción
Inclusion Criteria:
- Age between 18 and 70 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for elective laparoscopic cholecystectomy.
- Patients undergoing general anesthesia.
- Patients who provide written informed consent.
Exclusion Criteria:
-
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
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Group I: i-gel group
Patients receiving airway management with the i-gel supraglottic airway device
|
|
Grup II: SaCoVLM
Patients receiving airway management with the SaCoVLM supraglottic airway device
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
Periodo de tiempo: After device insertion and after pneumoperitoneum creation during surgery.
|
Oropharyngeal leak pressure (OLP) will be measured and compared between the i-gel and SaCoVLM groups to evaluate airway sealing performance during elective laparoscopic cholecystectomy..
|
After device insertion and after pneumoperitoneum creation during surgery.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First-Attempt Insertion Success Rate
Periodo de tiempo: During device insertion procedure
|
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
|
During device insertion procedure
|
|
Device Insertion Time
Periodo de tiempo: During device insertion procedure
|
The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.
|
During device insertion procedure
|
|
Gastric Tube Insertion Success Rate
Periodo de tiempo: Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
|
The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.
|
Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
|
|
Peak Airway Pressure (PAP)
Periodo de tiempo: 5 minutes after pneumoperitoneum is established.
|
Peak airway pressure values measured during mechanical ventilation and compared between study groups
|
5 minutes after pneumoperitoneum is established.
|
|
End-Tidal Carbon Dioxide (EtCO₂)
Periodo de tiempo: Throughout laparoscopic surgery.
|
End-tidal carbon dioxide values measured during surgery and compared between study groups.
|
Throughout laparoscopic surgery.
|
|
Postoperative Sore Throat
Periodo de tiempo: Within 24 hours after surgery.
|
The incidence of postoperative sore throat following removal of the supraglottic airway device.Postoperative sore throat severity assessed using an 11-point Numeric Rating Scale (NRS)
|
Within 24 hours after surgery.
|
|
Hoarseness
Periodo de tiempo: Within 24 hours after surgery.
|
The incidence of postoperative dysphagia following airway device use.
|
Within 24 hours after surgery.
|
|
Blood Staining and Mucosal Trauma
Periodo de tiempo: Immediately after device removal.
|
The incidence of blood staining on the device and evidence of mucosal trauma after device removal.
|
Immediately after device removal.
|
|
Hemodynamic Parameters
Periodo de tiempo: Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
|
Heart rate (beats per minute [bpm]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean heart rate values will be compared between the i-gel and SaCoVLM groups.Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean systolic blood pressure values will be compared between the i-gel and SaCoVLM groups.Mean arterial pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean arterial pressure values will be
|
Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Hatice Selçuk Kuşderci, Samsun University
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)
24 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- GOKAEK 2026/11/18
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .