AnesthesiaNCT06482983
The Effects of VC Versus PC Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery
A study testing Mechanical Ventilation Mode in people with Anesthesia and Gynecologic Cancer, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Anesthesia, Gynecologic Cancer, Mechanical Ventilation Complication
- What is being tested?
- Mechanical Ventilation Mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 Jul 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 age
- ASA 1-3
Who cannot join
- Under 18 years of age, over 70 years of age,
- ASA IV,
- history of severe chronic obstructive pulmonary disease (COPD, GOLD III or IV)
- ,-history of severe or uncontrolled bronchial asthma, presence of restrictive lung disease,
- history of any thoracic surgery operation, need for thoracic drainage before surgery
- patients receiving preoperative renal replacement therapy,
Show all 9Show fewer
- congestive heart failure (NYHA grade III or IV),
- extremely obese (body Mass Index, BMI > 35 Kg/m2)
- patients without patient consent
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
Umraniye research and education hospital
Istanbul, Umraniye, 34764
zeliha tuncel, ass prof, 5053577483, zeliha.tuncel@sbu.edu.tr
About this study
Official title: The Effects of Volume-controlled Ventilation Versus Pressure-controlled Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery
The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect.
Read the detailed description
In laparoscopic interventions, the Trendelenburg position should be applied and artificial pneumoperitoneum should be created by CO2 insufflation. Trendelenburg position is widely used in laparoscopic surgery and open abdominal surgery. The head-down position classically refers to a 45˚ inclination of the head. However, in gynecologic operations, this inclination is usually much more than 45 degrees and the position of the head is close to the floor. Feet are in lithotomy position. The blood flow is towards the head during surgery and the venous head is slowed down in the neck region due to the position. Most case reports and case series of venous complications, usually venous thromboembolism (VTE), associated with laparoscopic surgery have been reported in patients in reverse Trendelenburg with associated pneumoperitoneum.Increasing intra-abdominal pressure with pneumoperitoneum and the deep Trendelenburg position will move the diaphragm caudally, decreasing lung functional capacity (FRC). The major respiratory complications associated with the Trendelenburg position during laparoscopic surgery are mainly due to a combination of both the position and the associated pneumoperitoneum and the resulting pressure on the diaphragm. As this upward pressure must be balanced by increased airway pressures to adequately ventilate the patient, the patient is at risk of pneumothorax, atelectasis and mediastinal emphysema. These adverse respiratory effects are more pronounced and longer lasting in patients with comorbid lung disease such as chronic obstructive pulmonary disease. Anesthesiologists are acutely aware of this risk and therefore adjust various ventilation parameters to continue to limit the pressure at the alveolar level to improve oxygenation. Different modes of mechanical ventilation and different PEEP can cause an increase in intrathoracic pressure, as well as a decrease in venous return under vena cava inferior pressure due to increased intra-abdominal pressure. The Trendelenburg position increases preload and alters cardiac output. Since perioperative atelectasis may develop and oxygenation may be affected, prophylactic positive end-expiratory pressure (PEEP) is recommended intraoperatively. Trendelenburg position and pneumoperitoneum have been reported to increase intracranial pressure (ICP) and alter cerebral blood flow (CBF) or volume (CBV). Changes in ICP, CBF or CBV affect cerebral perfusion pressure. Therefore, gynecologic laparoscopic surgery may affect cerebral oxygenation by altering cerebral hemodynamics.
Since standard monitoring may not be sufficient to determine the conditions in which cerebral oxygenation is affected, monitoring techniques such as cerebral oximetry, which measures rSO2, have recently been used. Thanks to NIRS, cerebral oxygenation can be detected early before tissue hypoxia occurs. In the literature, there are few studies using NIRS in gynecologic laparoscopy operations with Trendelenburg and pneumoperitoneum.PCV-VG is the newest ventilation mode in anesthesia equipment. PCV-VG is an innovative ventilation mode that uses a decelerating flow and constant pressure. Ventilator parameters are automatically changed with each patient breath to deliver the target tidal volume without increasing airway pressures. It delivers the preset tidal volume with the lowest possible pressure. PCV-VG therefore has the advantages of both VCV and PCV to maintain target minute ventilation while producing a low incidence of barotrauma. The PCV-VG mode delivers breaths with the efficiency and clinical benefits of PCV, but still compensates for pressure changes with consistent tidal volumes. Because of its benefits, clinical applications during surgery have been reported. The VCV mode used in standard anesthesia practice can guarantee target minute ventilation but a constant flow rate can lead to higher peak inspiratory pressure (PIP), increasing the incidence of barotrauma and causing uneven distribution of pulmonary gases. To avoid high inspiratory pressures, a lower tidal volume (VT) and faster RR can be used, but lower VT is known to predispose the dependent lung to atelectasis and worsen arterial oxygenation. Pressure-controlled ventilation (PCV) mode has arrived as an alternative mode in laparoscopic surgeries. PCV delivers tidal volume at a preset pressure and inspiratory durationThe flow is slow, unlike VCV. This flow pattern has a high initial rise followed by a decline and helps to achieve tidal volume at lower peak inspiratory pressures and oxygenation is also better due to the initial high flow rates. However, with changing lung compliance the delivered tidal volume changes and there is always a risk of hypoventilation or hyperventilation. PCV minute volume, tidal volume should be closely monitored. With pressure control modes, barotrauma risk protection and effective oxygenation can be provided against airway pressure increase that may occur due to deep trendelenburg and intraabdominal pressure increase. The risk of atelectasis is reduced by close monitoring of lung compliance changes.
- Being tested
- Mechanical Ventilation Mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Ventilation ModeProcedure or surgery
Also called Pressure-controlled volume guaranteed mode ventilation, Pressure control mode ventilation
after intubation different ventilation mode (VC,PC,PC-VG)
| Study group | Role | What they receive |
|---|---|---|
| ventilation mode during surgery | Active comparator | Volume control mode (VC) n: 40 Receives: Procedure: Mechanical Ventilation Mode |
| Pressure-controlled volume guaranteed mode (PC-VG) ventilation | Active comparator | Pressure-controlled volume guaranteed mode (PC-VG) n:40 Receives: Procedure: Mechanical Ventilation Mode |
| Pressure control mode (PC) ventilation | Active comparator | Pressure control mode (PC) n:40 Receives: Procedure: Mechanical Ventilation Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary datas in laparoscopic gynecologic surgery.
peak airway pressure (minumum 40 cm H2O ,maksimum 40 cm H2O)
Measured: one week
cerebral datas in laparoscopic gynecologic
NIRS (20% change from baseline value)
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 May 2023
- Primary completion30 Sep 2024
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I: Volume control mode (VC) n: 40 Group II: Pressure-controlled volume guaranteed mode (PC-VG) n:40 Group III: Pressure control mode (PC) n:40
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482983
- Sponsor's protocol ID
- UERH-AR-ZT-07
- Status last verified
- Nov 2025
- First submitted
- 6 May 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Volume-controlled Ventilation Versus Pressure-controlled Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT06482983
- Acronym / sponsor ID
- UERH-AR-ZT-07
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Jul 2024 (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.
The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect.
Detailed description
In laparoscopic interventions, the Trendelenburg position should be applied and artificial pneumoperitoneum should be created by CO2 insufflation. Trendelenburg position is widely used in laparoscopic surgery and open abdominal surgery. The head-down position classically refers to a 45˚ inclination of the head. However, in gynecologic operations, this inclination is usually much more than 45 degrees and the position of the head is close to the floor. Feet are in lithotomy position. The blood flow is towards the head during surgery and the venous head is slowed down in the neck region due to the position. Most case reports and case series of venous complications, usually venous thromboembolism (VTE), associated with laparoscopic surgery have been reported in patients in reverse Trendelenburg with associated pneumoperitoneum.Increasing intra-abdominal pressure with pneumoperitoneum and the deep Trendelenburg position will move the diaphragm caudally, decreasing lung functional capacity (FRC). The major respiratory complications associated with the Trendelenburg position during laparoscopic surgery are mainly due to a combination of both the position and the associated pneumoperitoneum and the resulting pressure on the diaphragm. As this upward pressure must be balanced by increased airway pressures to adequately ventilate the patient, the patient is at risk of pneumothorax, atelectasis and mediastinal emphysema. These adverse respiratory effects are more pronounced and longer lasting in patients with comorbid lung disease such as chronic obstructive pulmonary disease. Anesthesiologists are acutely aware of this risk and therefore adjust various ventilation parameters to continue to limit the pressure at the alveolar level to improve oxygenation. Different modes of mechanical ventilation and different PEEP can cause an increase in intrathoracic pressure, as well as a decrease in venous return under vena cava inferior pressure due to increased intra-abdominal pressure. The Trendelenburg position increases preload and alters cardiac output. Since perioperative atelectasis may develop and oxygenation may be affected, prophylactic positive end-expiratory pressure (PEEP) is recommended intraoperatively. Trendelenburg position and pneumoperitoneum have been reported to increase intracranial pressure (ICP) and alter cerebral blood flow (CBF) or volume (CBV). Changes in ICP, CBF or CBV affect cerebral perfusion pressure. Therefore, gynecologic laparoscopic surgery may affect cerebral oxygenation by altering cerebral hemodynamics.
Since standard monitoring may not be sufficient to determine the conditions in which cerebral oxygenation is affected, monitoring techniques such as cerebral oximetry, which measures rSO2, have recently been used. Thanks to NIRS, cerebral oxygenation can be detected early before tissue hypoxia occurs. In the literature, there are few studies using NIRS in gynecologic laparoscopy operations with Trendelenburg and pneumoperitoneum.PCV-VG is the newest ventilation mode in anesthesia equipment. PCV-VG is an innovative ventilation mode that uses a decelerating flow and constant pressure. Ventilator parameters are automatically changed with each patient breath to deliver the target tidal volume without increasing airway pressures. It delivers the preset tidal volume with the lowest possible pressure. PCV-VG therefore has the advantages of both VCV and PCV to maintain target minute ventilation while producing a low incidence of barotrauma. The PCV-VG mode delivers breaths with the efficiency and clinical benefits of PCV, but still compensates for pressure changes with consistent tidal volumes. Because of its benefits, clinical applications during surgery have been reported. The VCV mode used in standard anesthesia practice can guarantee target minute ventilation but a constant flow rate can lead to higher peak inspiratory pressure (PIP), increasing the incidence of barotrauma and causing uneven distribution of pulmonary gases. To avoid high inspiratory pressures, a lower tidal volume (VT) and faster RR can be used, but lower VT is known to predispose the dependent lung to atelectasis and worsen arterial oxygenation. Pressure-controlled ventilation (PCV) mode has arrived as an alternative mode in laparoscopic surgeries. PCV delivers tidal volume at a preset pressure and inspiratory durationThe flow is slow, unlike VCV. This flow pattern has a high initial rise followed by a decline and helps to achieve tidal volume at lower peak inspiratory pressures and oxygenation is also better due to the initial high flow rates. However, with changing lung compliance the delivered tidal volume changes and there is always a risk of hypoventilation or hyperventilation. PCV minute volume, tidal volume should be closely monitored. With pressure control modes, barotrauma risk protection and effective oxygenation can be provided against airway pressure increase that may occur due to deep trendelenburg and intraabdominal pressure increase. The risk of atelectasis is reduced by close monitoring of lung compliance changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Group I: Volume control mode (VC) n: 40 Group II: Pressure-controlled volume guaranteed mode (PC-VG) n:40 Group III: Pressure control mode (PC) n:40
| Arm | Type | Receives |
|---|---|---|
| ventilation mode during surgery | Active comparator | Procedure: Mechanical Ventilation ModeVolume control mode (VC) n: 40 |
| Pressure-controlled volume guaranteed mode (PC-VG) ventilation | Active comparator | Procedure: Mechanical Ventilation ModePressure-controlled volume guaranteed mode (PC-VG) n:40 |
| Pressure control mode (PC) ventilation | Active comparator | Procedure: Mechanical Ventilation ModePressure control mode (PC) n:40 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 age
- ASA 1-3
Key exclusion criteria (9 listed)
- Under 18 years of age, over 70 years of age,
- ASA IV,
- history of severe chronic obstructive pulmonary disease (COPD, GOLD III or IV)
- ,-history of severe or uncontrolled bronchial asthma, presence of restrictive lung disease,
- history of any thoracic surgery operation, need for thoracic drainage before surgery
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 |
|---|---|---|
| Mechanical Ventilation ModeAlso: Pressure-controlled volume guaranteed mode ventilation, Pressure control mode ventilationafter intubation different ventilation mode (VC,PC,PC-VG) | Procedure or surgery | Pressure control mode (PC) ventilation, Pressure-controlled volume guaranteed mode (PC-VG) ventilation, ventilation mode during surgery |
Primary outcome
pulmonary datas in laparoscopic gynecologic surgery.
Time frame: one week
peak airway pressure (minumum 40 cm H2O ,maksimum 40 cm H2O)
cerebral datas in laparoscopic gynecologic
Time frame: one week
NIRS (20% change from baseline value)
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 19 Nov 2025.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Umraniye research and education hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation Mode in people with Anesthesia and Gynecologic Cancer, run by Umraniye Education 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 2 inclusion and 9 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 19 Nov 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary datas in laparoscopic gynecologic surgery. (time frame: one week). The study lists 2 primary outcomes in all. 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 19 Nov 2025.