Postoperative Pulmonary ComplicationsNCT07536464
PEEP Strategies and Mechanical Power in Robotic Surgery
A study testing Fixed PEEP Ventilation, Decremental PEEP Strategy and Incremental PEEP Strategy in people with Postoperative Pulmonary Complications and Impaired Oxygenation, run by Ankara City Hospital Bilkent.
Trial summary
Robotic surgery requires pneumoperitoneum and steep Trendelenburg positioning, which significantly impair respiratory mechanics and increase the risk of postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pulmonary Complications, Impaired Oxygenation, Mechanical Ventilation
- What is being tested?
- Fixed PEEP Ventilation, Decremental PEEP Strategy and Incremental PEEP Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Jun 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
- Age>= 18
- ASA I-III
- Elective robotic surgery
Who cannot join
- COPD GOLD ≥2
- Restrictive lung disease
- BMI >40 kg/m²
- Heart failure
- Preoperative oxygen requirement
- Need for postoperative mechanical ventilation
- Refusal to participate
About this study
Official title: Comparison of Incremental, Decremental, and Fixed PEEP Strategies on Mechanical Power and Postoperative Oxygenation in Robotic Surgery: A Prospective Randomized Controlled Trial
Robotic surgery requires pneumoperitoneum and steep Trendelenburg positioning, which significantly impair respiratory mechanics and increase the risk of postoperative pulmonary complications.
Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment; however, fixed PEEP strategies may not be optimal for all patients. Individualized PEEP titration strategies, including incremental and decremental approaches, may better optimize lung mechanics.
This randomized controlled trial aims to compare the effects of incremental, decremental, and fixed PEEP strategies on cumulative mechanical power (MP-AUC) and postoperative oxygenation in patients undergoing robotic surgery.
- Being tested
- Fixed PEEP Ventilation, Decremental PEEP Strategy, Incremental PEEP Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed PEEP VentilationProcedure or surgery
Patients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure.
Decremental PEEP StrategyProcedure or surgery
PEEP is gradually decreased from a higher level to determine the optimal PEEP associated with the lowest driving pressure or lowest mechanical power, and this level is maintained during surgery.
Incremental PEEP StrategyProcedure or surgery
PEEP is gradually increased from a lower level to identify the optimal PEEP corresponding to the lowest driving pressure or mechanical power, and this level is maintained during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Fixed PEEP | Active comparator | Ventilation with constant PEEP of 5 cmH₂O throughout surgery. Receives: Procedure: Fixed PEEP Ventilation; Procedure: Decremental PEEP Strategy; Procedure: Incremental PEEP Strategy |
| Decremental PEEP | Experimental | PEEP is gradually decreased to identify the level associated with the lowest driving pressure or lowest mechanical power. Receives: Procedure: Fixed PEEP Ventilation; Procedure: Decremental PEEP Strategy; Procedure: Incremental PEEP Strategy |
| Incremental PEEP | Experimental | PEEP is gradually increased to determine the optimal level corresponding to the lowest driving pressure or mechanical power. Receives: Procedure: Fixed PEEP Ventilation; Procedure: Decremental PEEP Strategy; Procedure: Incremental PEEP Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Mechanical Power (MP-AUC)
Total energy delivered to the respiratory system during surgery
Measured: During surgery (from intubation to extubation)
Secondary outcomes (3)
PaO₂/FiO₂ ratio
Measured: Intraoperative period and postoperative period (within 2 hours)
Oxygenation Index (OSI)
Measured: Postoperative 2 hours
Postoperative Pulmonary Complications (PPC)
Measured: Within 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536464
- Sponsor's protocol ID
- E26-14833
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Incremental, Decremental, and Fixed PEEP Strategies on Mechanical Power and Postoperative Oxygenation in Robotic Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07536464
- Acronym / sponsor ID
- E26-14833
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Apr 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.
Robotic surgery requires pneumoperitoneum and steep Trendelenburg positioning, which significantly impair respiratory mechanics and increase the risk of postoperative pulmonary complications.
Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment; however, fixed PEEP strategies may not be optimal for all patients. Individualized PEEP titration strategies, including incremental and decremental approaches, may better optimize lung mechanics.
This randomized controlled trial aims to compare the effects of incremental, decremental, and fixed PEEP strategies on cumulative mechanical power (MP-AUC) and postoperative oxygenation in patients undergoing robotic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fixed PEEP | Active comparator | Procedure: Fixed PEEP Ventilation, Procedure: Decremental PEEP Strategy, Procedure: Incremental PEEP StrategyVentilation with constant PEEP of 5 cmH₂O throughout surgery. |
| Decremental PEEP | Experimental | Procedure: Fixed PEEP Ventilation, Procedure: Decremental PEEP Strategy, Procedure: Incremental PEEP StrategyPEEP is gradually decreased to identify the level associated with the lowest driving pressure or lowest mechanical power. |
| Incremental PEEP | Experimental | Procedure: Fixed PEEP Ventilation, Procedure: Decremental PEEP Strategy, Procedure: Incremental PEEP StrategyPEEP is gradually increased to determine the optimal level corresponding to the lowest driving pressure or mechanical power. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>= 18
- ASA I-III
- Elective robotic surgery
Key exclusion criteria (7 listed)
- COPD GOLD ≥2
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 |
|---|---|---|
| Fixed PEEP VentilationPatients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure. | Procedure or surgery | Decremental PEEP, Fixed PEEP, Incremental PEEP |
| Decremental PEEP StrategyPEEP is gradually decreased from a higher level to determine the optimal PEEP associated with the lowest driving pressure or lowest mechanical power, and this level is maintained during surgery. | Procedure or surgery | Decremental PEEP, Fixed PEEP, Incremental PEEP |
| Incremental PEEP StrategyPEEP is gradually increased from a lower level to identify the optimal PEEP corresponding to the lowest driving pressure or mechanical power, and this level is maintained during surgery. | Procedure or surgery | Decremental PEEP, Fixed PEEP, Incremental PEEP |
Primary outcome
Cumulative Mechanical Power (MP-AUC)
Time frame: During surgery (from intubation to extubation)
Total energy delivered to the respiratory system during surgery
3 secondary outcomes
PaO₂/FiO₂ ratio
Time frame: Intraoperative period and postoperative period (within 2 hours)
Oxygenation Index (OSI)
Time frame: Postoperative 2 hours
Postoperative Pulmonary Complications (PPC)
Time frame: Within 7 postoperative days
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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed PEEP Ventilation, Decremental PEEP Strategy and Incremental PEEP Strategy in people with Postoperative Pulmonary Complications and Impaired Oxygenation, run by Ankara City Hospital Bilkent.
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 3 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: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Cumulative Mechanical Power (MP-AUC) (time frame: During surgery (from intubation to extubation)). 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 17 Apr 2026.