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Recruiting NCT07670494

Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery

No phase Interventional Laparoscopic Cholecystectomy Mechanical Ventilation Ventilator-Induced Lung Injury

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: Volume-Controlled Ventilation (VCV), Pressure-Regulated Volume Control (PRVC).
Who it may be relevant to
Registry conditions: Laparoscopic Cholecystectomy, Mechanical Ventilation, Ventilator-Induced Lung Injury. Basic parameters: from 18 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
Turkey (Türkiye)
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

Comparison of Mechanical Power in Pressure-Regulated Volume Control and Volume-Controlled Ventilation Modes During Laparoscopic Cholecystectomy

Overview

This study investigates how different breathing machine (ventilator) settings affect the energy delivered to the lungs during surgery. Mechanical power is a measure of this energy, and high levels can sometimes lead to lung irritation. In clinical practice, a mode called Pressure-Regulated Volume Control (PRVC) is often used because it lowers the "peak" pressure in the airways, which is generally thought to be safer. However, doctors have noticed that even though the peak pressure goes down in PRVC mode, the total mechanical power displayed on the monitor might actually increase compared to the standard Volume-Controlled Ventilation (VCV) mode. In this study, patients undergoing gallbladder surgery will be monitored using both ventilation modes in a random order. The researchers will compare the machine-calculated mechanical power for both modes to see if the perceived benefit of lower peak pressure in PRVC actually results in lower overall energy transfer to the lungs.

Interventions

  • Device Volume-Controlled Ventilation (VCV)
    Participants will be ventilated with the traditional Volume-Controlled Ventilation (VCV) mode. Tidal volume, respiratory rate, PEEP, and I:E ratio will be set according to the study protocol and kept constant during the measurement period.
  • Device Pressure-Regulated Volume Control (PRVC)
    Participants will be ventilated with the Pressure-Regulated Volume Control (PRVC) mode. This is a hybrid mode that uses a decelerating flow to deliver the target tidal volume at the lowest possible pressure. Settings will be identical to the VCV mode for each patient.

Primary outcome measures

  • Device-Displayed Mechanical Power [Time frame: At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).]

Eligibility criteria

Inclusion criteria

  • Patients undergoing elective laparoscopic cholecystectomy surgery.
  • Patients between 18 and 75 years of age.
  • American Society of Anesthesiologists (ASA) physical status I, II or III.
  • Body Mass Index (BMI) between 18.5 and 35 kg/m².
  • Voluntary written informed consent for participation.

Exclusion criteria

  • History of significant chronic obstructive pulmonary disease (COPD) or asthma.
  • Previous lung resection or major thoracic surgery.
  • Heavy smokers (more than 20 cigarettes per day).
  • Presence of spontaneous breathing effort during mechanical ventilation.
  • Conversion from laparoscopic surgery to open surgery during the procedure.
  • Emergency surgery cases.
  • Known pregnancy.

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 1 center
  • Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital — Yenimahalle

Identifiers

NCT: NCT07670494 · 2026-06/133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗