Recruitment ManeuverNCT07000448
Optimal Ventilation Strategies in Laparoscopic Hysterectomy
A study testing Dynamic compliance guided individualized positive end-expiratory pressure titration strategy and standardized 5 PEEP in people with Recruitment Maneuver and Individualized PEEP, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate whether individualized PEEP application improves respiratory function and reduces the incidence of postoperative pulmonary complications (PPCs) in patients undergoing laparoscopic total hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Recruitment Maneuver, Individualized PEEP, Total Hysterectomy
- What is being tested?
- Dynamic compliance guided individualized positive end-expiratory pressure titration strategy and standardized 5 PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2022to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled for elective laparoscopic total hysterectomy
- ASA physical status I-III
- BMI ≤30 kg/m²
- Anticipated surgical duration >2 hours
Who cannot join
- Pre-existing neuromuscular disorders
- NYHA class III/IV heart failure
- OSAS
- Previous lung surgery
- Severe pulmonary disease (FEV1 <50% predicted)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Effects of Personalized PEEP Titration on Postoperative Pulmonary Outcomes in Laparoscopic Hysterectomy
The aim of this study was to investigate whether individualized PEEP application improves respiratory function and reduces the incidence of postoperative pulmonary complications (PPCs) in patients undergoing laparoscopic total hysterectomy. Investigators hypothesized that individualized PEEP would improve pulmonary oxygenation and reduce the incidence of postoperative pulmonary complications.
Read the detailed description
The study included 113 patients who met the criteria and underwent elective laparoscopic total hysterectomy.
In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. During this maneuver, the ventilator was switched to pressure-controlled mode, the I:E ratio was increased to 1:1, FiO₂ was increased to 80%, and the respiratory rate was set to 15/min. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every 5 respiratory cycles, and an airway opening pressure of 40 cmH₂O was obtained.
For optimal individual PEEP titration, the dynamic compliance values observed on the ventilator monitor were recorded when the PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles, and the PEEP level at which the highest compliance value was obtained was determined. The value 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. The recruitment maneuver was repeated at specified time points during the surgical procedure and upon disconnection of the ventilator circuit.
Data collection was performed at several time points; before induction (T1), only hemodynamic data were recorded. Before pneumoperitoneum, 5 minutes after induction (T2) with the patient in the supine position, 20 minutes after the onset of pneumoperitoneum (T3) in the Trendelenburg position, and 60 minutes after the onset of pneumoperitoneum (T4) mechanical ventilation and hemodynamic parameters were recorded.
- Conditions
- Recruitment Maneuver, Individualized PEEP, Total Hysterectomy, Postoperative Pulmonary Complications
- Being tested
- Dynamic compliance guided individualized positive end-expiratory pressure titration strategy, standardized 5 PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic compliance guided individualized positive end-expiratory pressure titration strategyProcedure or surgery
For optimal individual PEEP titration, dynamic compliance values observed on the ventilator monitor were recorded when PEEP reached 20 cmH₂O.
standardized 5 PEEPProcedure or surgery
Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP and no recruitment maneuver was performed.
| Study group | Role | What they receive |
|---|---|---|
| individualized PEEP (PEEPi) | Experimental | In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every five respiratory cycles, and an airway opening pressure of 40 cmH₂O was achieved. Dynamic compliance values observed on the ventilator monitor were recorded for optimal individual PEEP titration when PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles to determine the PEEP level at which the highest compliance value was achieved. 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. Receives: Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy |
| PEEP 5 | Active comparator | Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP, and no recruitment maneuver was performed. Receives: Procedure: standardized 5 PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications (PPC)
PPC included clinical conditions such as atelectasis, hypoxemia (PaO₂ < 8.0 kPa or SpO₂ < 90% on room air), pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, bronchospasm, pneumothorax, reintubation or need for non-invasive ventilation support.
Measured: within 7 days after surgery
Secondary outcomes (4)
Intraoperative respiratory mechanics parameter
Driving pressure
Measured: within intraoperative period
Respiratory mechanics parameter
Dynamic compliance
Measured: intraoperatively
Mechanic ventilation parameter
Pplatteau
Measured: during intraoperative period
Intensive care
Intensive care unit (ICU) admission
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start9 Dec 2022
- Primary completion25 Apr 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recruitment ManeuverStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Beyhan Guner, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Beyhan Guner, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000448
- Sponsor's protocol ID
- 2022-394
- Status last verified
- Sep 2025
- First submitted
- 21 May 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized PEEP Titration on Postoperative Pulmonary Outcomes in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07000448
- Acronym / sponsor ID
- 2022-394
- Conditions
- Recruitment Maneuver, Individualized PEEP, Total Hysterectomy, Postoperative Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 3 Jun 2025 (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 this study was to investigate whether individualized PEEP application improves respiratory function and reduces the incidence of postoperative pulmonary complications (PPCs) in patients undergoing laparoscopic total hysterectomy. Investigators hypothesized that individualized PEEP would improve pulmonary oxygenation and reduce the incidence of postoperative pulmonary complications.
Detailed description
The study included 113 patients who met the criteria and underwent elective laparoscopic total hysterectomy.
In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. During this maneuver, the ventilator was switched to pressure-controlled mode, the I:E ratio was increased to 1:1, FiO₂ was increased to 80%, and the respiratory rate was set to 15/min. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every 5 respiratory cycles, and an airway opening pressure of 40 cmH₂O was obtained.
For optimal individual PEEP titration, the dynamic compliance values observed on the ventilator monitor were recorded when the PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles, and the PEEP level at which the highest compliance value was obtained was determined. The value 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. The recruitment maneuver was repeated at specified time points during the surgical procedure and upon disconnection of the ventilator circuit.
Data collection was performed at several time points; before induction (T1), only hemodynamic data were recorded. Before pneumoperitoneum, 5 minutes after induction (T2) with the patient in the supine position, 20 minutes after the onset of pneumoperitoneum (T3) in the Trendelenburg position, and 60 minutes after the onset of pneumoperitoneum (T4) mechanical ventilation and hemodynamic parameters were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized PEEP (PEEPi) | Experimental | Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategyIn the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every five respiratory cycles, and an airway opening pressure of 40 cmH₂O was achieved. Dynamic compliance values observed on the ventilator monitor were recorded for optimal individual PEEP titration when PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles to determine the PEEP level at which the highest compliance value was achieved. 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. |
| PEEP 5 | Active comparator | Procedure: standardized 5 PEEPPatients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP, and no recruitment maneuver was performed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Scheduled for elective laparoscopic total hysterectomy
- ASA physical status I-III
- BMI ≤30 kg/m²
- Anticipated surgical duration >2 hours
Key exclusion criteria (5 listed)
- Pre-existing neuromuscular disorders
- NYHA class III/IV heart failure
- OSAS
- Previous lung surgery
- Severe pulmonary disease (FEV1 <50% predicted)
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 |
|---|---|---|
| Dynamic compliance guided individualized positive end-expiratory pressure titration strategyFor optimal individual PEEP titration, dynamic compliance values observed on the ventilator monitor were recorded when PEEP reached 20 cmH₂O. | Procedure or surgery | individualized PEEP (PEEPi) |
| standardized 5 PEEPPatients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP and no recruitment maneuver was performed. | Procedure or surgery | PEEP 5 |
Primary outcome
Postoperative pulmonary complications (PPC)
Time frame: within 7 days after surgery
PPC included clinical conditions such as atelectasis, hypoxemia (PaO₂ < 8.0 kPa or SpO₂ < 90% on room air), pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, bronchospasm, pneumothorax, reintubation or need for non-invasive ventilation support.
4 secondary outcomes
Intraoperative respiratory mechanics parameter
Time frame: within intraoperative period
Respiratory mechanics parameter
Time frame: intraoperatively
Mechanic ventilation parameter
Time frame: during intraoperative period
Intensive care
Time frame: within 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Recruitment Maneuver
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingObservational study
Individualized vs Standard PEEP and Oxygen Reserve Index in Laparoscopic Hernia Surgery
Atelectasis, Perioperative Oxygenation
Not yet recruiting
Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy
Atelectasis, Postoperative Pulmonary Complications
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
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. This study is not recruiting at the moment.
Beyhan Guner, MD principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic compliance guided individualized positive end-expiratory pressure titration strategy and standardized 5 PEEP in people with Recruitment Maneuver and Individualized PEEP, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 5 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: finished, as of the sponsor's last update on 22 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (PPC) (time frame: within 7 days after surgery). 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 22 Sep 2025.