Topp luftvägstryck och andningsmekanik under PRVC-ventilation vid laparoskopisk kirurgi
"Topp luftvägstryck och andningsmekanik vid tryckreglerad volymkontrollerad ventilation hos patienter som genomgår laparoskopisk bukkirurgi: en prospektiv observationsstudie"
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Riyadh, Saudiarabien
- SpecializedMedicalCenter
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peak Airway Pressure
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dynamic Compliance
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: At 0, 5, and 10 minutes intraoperatively
|
Mean arterial pressure measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
|
|
Minute Ventilation
Tidsram: At 0, 5, and 10 minutes intraoperatively
|
Minute ventilation recorded from the anesthesia workstation during controlled ventilation. |
At 0, 5, and 10 minutes intraoperatively
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB-002-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
No, individual participant data (IPD) will not be shared.
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