Presión pico en la vía aérea y mecánica respiratoria durante la ventilación PRVC en cirugía laparoscópica
Presión máxima en la vía aérea y mecánica respiratoria durante la ventilación con control de volumen regulado por presión en pacientes sometidos a cirugía abdominal laparoscópica: un estudio observacional prospectivo
This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.
The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.
Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.
This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, plateau pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at three predefined stages, each after a minimum 5-minute stabilization interval: after induction and intubation (supine, before pneumoperitoneum), after establishment of pneumoperitoneum, and after final surgical positioning.
The primary outcome will be the change in peak airway pressure across the three stages. Secondary outcomes include dynamic compliance and other ventilatory and hemodynamic parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Riyadh, Arabia Saudita
- SpecializedMedicalCenter
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
Descripción
Inclusion Criteria:
- Adult patients aged 18-65 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- ASA physical status I-II
- Patients requiring mechanical ventilation using PRVC mode
- Provided informed consent
Exclusion Criteria:
- Patients with significant cardiopulmonary disease
- Chronic obstructive pulmonary disease or restrictive lung disease
- Morbid obesity (BMI > 35 kg/m²)
- Pregnancy
- Emergency surgeries
- Patients with anticipated difficult airway
- Refusal to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Single Cohort
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points. |
Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak Airway Pressure
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
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Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings. |
At 0, 5, and 10 minutes intraoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dynamic Compliance
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
|
Dynamic lung compliance (Cdyn) measured intraoperatively using standard anesthesia monitoring at predefined time points. |
At 0, 5, and 10 minutes intraoperatively
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Plateau Pressure
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
|
Plateau pressure (Pplat) measured during controlled ventilation using the anesthesia workstation. |
At 0, 5, and 10 minutes intraoperatively
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|
End-tidal Carbon Dioxide
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
|
End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation. |
At 0, 5, and 10 minutes intraoperatively
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|
Mean Airway Pressure
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
|
Mean airway pressure measured intraoperatively using the anesthesia workstation. |
At 0, 5, and 10 minutes intraoperatively
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Oxygen Saturation
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
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Peripheral oxygen saturation (SpO2) monitored continuously during surgery. |
At 0, 5, and 10 minutes intraoperatively
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Heart Rate (beats/min)
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
|
Heart rate measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
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Mean Arterial Pressure (mmHg)
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
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Mean arterial pressure measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
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Minute Ventilation
Periodo de tiempo: At 0, 5, and 10 minutes intraoperatively
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Minute ventilation recorded from the anesthesia workstation during controlled ventilation. |
At 0, 5, and 10 minutes intraoperatively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- IRB-002-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
No, individual participant data (IPD) will not be shared.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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