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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| arif timuroglu, MD | Contact | +905072601980 | ariftimuroglu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital | Recruiting | Yenimahalle | Ankara | 06370 | Turkey (Türkiye) |
The de-identified individual participant data (including study protocol and statistical analysis plan) will be made available upon reasonable request to the corresponding author, following the publication of the study results.
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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.
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The data will be coded and analyzed by a researcher blinded to the ventilation mode sequences
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| 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. |
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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