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Not yet recruiting NCT07543939

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

Observational Intraoperative Ventilation Respiratory Mechanics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRVC Ventilation.
Who it may be relevant to
Registry conditions: Intraoperative Ventilation, Respiratory Mechanics. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study

Overview

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.

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.

Interventions

  • Other PRVC Ventilation
    Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced.

Primary outcome measures

  • Peak Airway Pressure [Time frame: At 0, 5, and 10 minutes intraoperatively]
Secondary outcome measures (8)
  • Dynamic Compliance [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Plateau Pressure [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • End-tidal Carbon Dioxide [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Mean Airway Pressure [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Oxygen Saturation [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Heart Rate (beats/min) [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Mean Arterial Pressure (mmHg) [Time frame: At 0, 5, and 10 minutes intraoperatively]
  • Minute Ventilation [Time frame: At 0, 5, and 10 minutes intraoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07543939 · IRB-002-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗