- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543939
Peak Airway Pressure and Respiratory Mechanics During PRVC Ventilation in Laparoscopic Surgery
Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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, tidal volume, respiratory rate, and dynamic compliance will be recorded at predefined time points: after induction, after pneumoperitoneum, and at steady-state intraoperative conditions.
The primary outcome will be peak airway pressure. Secondary outcomes include dynamic compliance and other ventilatory parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Salaheldin A Abdelaziz Ahmed, MD
- Phone Number: +201001308006
- Email: saladin28.sa@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Airway Pressure
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Compliance
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: At 0, 5, and 10 minutes intraoperatively
|
Mean arterial pressure measured intraoperatively using standard monitoring
|
At 0, 5, and 10 minutes intraoperatively
|
|
Minute Ventilation
Time Frame: At 0, 5, and 10 minutes intraoperatively
|
Minute ventilation recorded from the anesthesia workstation during controlled ventilation.
|
At 0, 5, and 10 minutes intraoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-002-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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