Laparoscopic Cholecystectomy, Mechanical Ventilation, Ventilator-Induced Lung Injury
Conditions
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.
Interventions
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.
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.
Sponsors
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
The data will be coded and analyzed by a researcher blinded to the ventilation mode sequences
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-Displayed Mechanical Power | At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC). | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTarif timuroglu, MD
Outcome results
None listed