Pression de pointe des voies aériennes et mécanique respiratoire pendant la ventilation PRVC en chirurgie laparoscopique
Pression de crête des voies aériennes et mécanique respiratoire pendant la ventilation à volume contrôlé régulé par pression chez les patients subissant une chirurgie abdominale laparoscopique : une étude observationnelle prospective
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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-
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Riyadh, Arabie Saoudite
- SpecializedMedicalCenter
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak Airway Pressure
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dynamic Compliance
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: At 0, 5, and 10 minutes intraoperatively
|
Mean arterial pressure measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
|
|
Minute Ventilation
Délai: At 0, 5, and 10 minutes intraoperatively
|
Minute ventilation recorded from the anesthesia workstation during controlled ventilation. |
At 0, 5, and 10 minutes intraoperatively
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB-002-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No, individual participant data (IPD) will not be shared.
Informations sur les médicaments et les dispositifs, documents d'étude
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