Laparoscopic CholecystectomyNCT07670494
Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery
A study of Laparoscopic Cholecystectomy and Mechanical Ventilation, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Mechanical Ventilation, Ventilator-Induced Lung Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
Yenimahalle, Ankara, 06370
arif timuroglu, 05072601980, ariftimuroglu@yahoo.com
About this study
Official title: Comparison of Mechanical Power in Pressure-Regulated Volume Control and Volume-Controlled Ventilation Modes During Laparoscopic Cholecystectomy
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.
- Being tested
- Volume-Controlled Ventilation (VCV), Pressure-Regulated Volume Control (PRVC)
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Volume-Controlled Ventilation (VCV); Device: Pressure-Regulated Volume Control (PRVC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026
- Primary completion10 Aug 2026 (estimated)
- Study completion12 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Timuroğlu, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670494
- Sponsor's protocol ID
- 2026-06/133
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mechanical Power in Pressure-Regulated Volume Control and Volume-Controlled Ventilation Modes During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07670494
- Acronym / sponsor ID
- 2026-06/133
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group A; VCV First, Then PRVC | Experimental | Device: Volume-Controlled Ventilation (VCV), Device: Pressure-Regulated Volume Control (PRVC)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. |
| group B; PRVC First, Then VCV | Experimental | Device: Volume-Controlled Ventilation (VCV), Device: Pressure-Regulated Volume Control (PRVC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | group A; VCV First, Then PRVC, group B; PRVC First, Then VCV |
| 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. | Device | group A; VCV First, Then PRVC, group B; PRVC First, Then VCV |
Primary outcome
Device-Displayed Mechanical Power
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laparoscopic Cholecystectomy and Mechanical Ventilation, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact arif timuroglu, MD (+905072601980, ariftimuroglu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-Displayed Mechanical Power (time frame: At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.