Peak Airway Pressure and Respiratory Mechanics During PRVC Ventilation in Laparoscopic Surgery

April 18, 2026 updated by: Specialized Medical Center (SMC)

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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