Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery

NCT07670494 | Recruiting

• 1 other identifier: 2026-06/133
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy; Mechanical Ventilation; Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Device-Displayed Mechanical Power

  The mechanical power value (expressed in Joules per minute - J/min) is automatically calculated and displayed on the monitor of the Mindray A9 anesthesia machine. This value represents the total energy delivered by the ventilator to the patient's respiratory system per minute. The study aims to compare how this machine-calculated value differs between the Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Control (PRVC) modes under identical clinical conditions.

  At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).

Study Arms (2)

group A; VCV First, Then PRVC

EXPERIMENTAL

Following the stabilization of pneumoperitoneum, participants will be ventilated using the Volume-Controlled Ventilation (VCV) mode for 10 minutes. At the end of this period, respiratory data and mechanical power values will be recorded. Immediately after, the ventilator will be switched to the Pressure-Regulated Volume Control (PRVC) mode with equivalent settings. After another 10-minute stabilization period in PRVC mode, a second set of measurements will be recorded.

Device: Volume-Controlled Ventilation (VCV); Device: Pressure-Regulated Volume Control (PRVC)

group B; PRVC First, Then VCV

EXPERIMENTAL

Following the stabilization of pneumoperitoneum, participants will be ventilated using the Pressure-Regulated Volume Control (PRVC) mode for 10 minutes. At the end of this period, respiratory data and mechanical power values will be recorded. Immediately after, the ventilator will be switched to the Volume-Controlled Ventilation (VCV) mode with equivalent settings. After another 10-minute stabilization period in VCV mode, a second set of measurements will be recorded.

Device: Volume-Controlled Ventilation (VCV); Device: Pressure-Regulated Volume Control (PRVC)

Interventions

Volume-Controlled Ventilation (VCV) DEVICE

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.

group A; VCV First, Then PRVC; group B; PRVC First, Then VCV

Pressure-Regulated Volume Control (PRVC) DEVICE

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.

group A; VCV First, Then PRVC; group B; PRVC First, Then VCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital

Yenimahalle, Ankara, 06370, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

arif timuroglu, MD

CONTACT

+905072601980; ariftimuroglu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data will be coded and analyzed by a researcher blinded to the ventilation mode sequences
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized, crossover clinical study. Following the establishment of pneumoperitoneum and a 10-minute stabilization period, each participant will receive both Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Control (PRVC) modes. The sequence of the ventilation modes (either VCV then PRVC or PRVC then VCV) will be determined by computer-generated randomization. A 10-minute stabilization period will be provided after each mode change before recording respiratory parameters and mechanical power values. Each patient will serve as their own control.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)