Pressão Máxima nas Vias Aéreas e Mecânica Respiratória Durante Ventilação PRVC em Cirurgia Laparoscópica
Pico de Pressão nas Vias Aéreas e Mecânica Respiratória Durante Ventilação Controlada por Volume com Regulação de Pressão em Pacientes Submetidos a Cirurgia Abdominal Laparoscópica: Um Estudo 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Riyadh, Arábia Saudita
- SpecializedMedicalCenter
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak Airway Pressure
Prazo: At 0, 5, and 10 minutes intraoperatively
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dynamic Compliance
Prazo: 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
|
|
Plateau Pressure
Prazo: 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
|
|
End-tidal Carbon Dioxide
Prazo: At 0, 5, and 10 minutes intraoperatively
|
End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation. |
At 0, 5, and 10 minutes intraoperatively
|
|
Mean Airway Pressure
Prazo: At 0, 5, and 10 minutes intraoperatively
|
Mean airway pressure measured intraoperatively using the anesthesia workstation. |
At 0, 5, and 10 minutes intraoperatively
|
|
Oxygen Saturation
Prazo: At 0, 5, and 10 minutes intraoperatively
|
Peripheral oxygen saturation (SpO2) monitored continuously during surgery. |
At 0, 5, and 10 minutes intraoperatively
|
|
Heart Rate (beats/min)
Prazo: At 0, 5, and 10 minutes intraoperatively
|
Heart rate measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
|
|
Mean Arterial Pressure (mmHg)
Prazo: At 0, 5, and 10 minutes intraoperatively
|
Mean arterial pressure measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
|
|
Minute Ventilation
Prazo: At 0, 5, and 10 minutes intraoperatively
|
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IRB-002-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
No, individual participant data (IPD) will not be shared.
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