Robotic SurgeryNCT07467135
Lung Mechanics and Ventilation Efficiency in Robotic Surgery
An observational study of Robotic Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Robotic surgery requires pneumoperitoneum and specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Robotic Surgery
- What is being tested?
- Intraoperative Mechanical Ventilation Monitoring
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 14 Jun 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation. Robotic procedures from different surgical specialties such as urology, gynecology, and general surgery will be included.
Who may be able to join
- Age ≥ 18 years
- Patients undergoing robotic surgery
- General anesthesia with mechanical ventilation
- Written informed consent
Who cannot join
- Severe chronic pulmonary disease
- Refusal to participate
- Missing intraoperative ventilatory data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-Specific Evaluation of Lung Mechanics and Ventilation Efficiency During Robotic Surgery: A Prospective Observational Cohort Study
Robotic surgery requires pneumoperitoneum and specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing respiratory mechanics and gas exchange.
Previous studies have primarily evaluated respiratory mechanics during robotic surgery at single time points or within specific surgical procedures. However, dynamic changes occurring during critical phases of robotic surgery have rarely been evaluated prospectively.
This prospective observational cohort study aims to evaluate phase-specific changes in lung mechanics and ventilation efficiency during robotic surgery. Key parameters including mechanical power (MP), ventilation efficiency index (VEI), static compliance, and driving pressure will be analyzed across predefined intraoperative phases.
- Conditions
- Robotic Surgery
- Being tested
- Intraoperative Mechanical Ventilation Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Mechanical Ventilation MonitoringOther
Prospective recording of ventilatory parameters and respiratory mechanics during robotic surgery under general anesthesia. Measurements will be obtained at predefined surgical phases (after intubation, pneumoperitoneum initiation, steep Trendelenburg positioning, undocking, and before extubation). Recorded parameters include tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, arterial blood gas measurements, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Surgery | Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation. Intraoperative respiratory mechanics and gas exchange parameters will be prospectively recorded during predefined phases of robotic surgery (T0-T4). Parameters include ventilatory settings, airway pressures, arterial blood gas values, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index. The study evaluates phase-specific changes in lung mechanics and ventilation efficiency during robotic surgical procedures. Receives: Other: Intraoperative Mechanical Ventilation Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Efficiency Index (VEI) change across robotic surgery phases
Evaluation of VEI changes between predefined intraoperative phases.
Measured: Intraoperative (T0-T4)
Secondary outcomes (2)
Mechanical Power Change
Evaluation of mechanical power changes across surgical phases.
Measured: intraoperative
Static Lung Compliance Change
Evaluation of static compliance changes during robotic surgery.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completion1 Apr 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
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
- NCT07467135
- Sponsor's protocol ID
- TABED1-26-2262
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-Specific Evaluation of Lung Mechanics and Ventilation Efficiency During Robotic Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07467135
- Acronym / sponsor ID
- TABED1-26-2262
- Conditions
- Robotic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 12 Mar 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 specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing respiratory mechanics and gas exchange.
Previous studies have primarily evaluated respiratory mechanics during robotic surgery at single time points or within specific surgical procedures. However, dynamic changes occurring during critical phases of robotic surgery have rarely been evaluated prospectively.
This prospective observational cohort study aims to evaluate phase-specific changes in lung mechanics and ventilation efficiency during robotic surgery. Key parameters including mechanical power (MP), ventilation efficiency index (VEI), static compliance, and driving pressure will be analyzed across predefined intraoperative phases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Surgery | – | Other: Intraoperative Mechanical Ventilation MonitoringAdult patients undergoing robotic surgery under general anesthesia with mechanical ventilation. Intraoperative respiratory mechanics and gas exchange parameters will be prospectively recorded during predefined phases of robotic surgery (T0-T4). Parameters include ventilatory settings, airway pressures, arterial blood gas values, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index. The study evaluates phase-specific changes in lung mechanics and ventilation efficiency during robotic surgical procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation. Robotic procedures from different surgical specialties such as urology, gynecology, and general surgery will be included.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients undergoing robotic surgery
- General anesthesia with mechanical ventilation
- Written informed consent
Key exclusion criteria (3 listed)
- Severe chronic pulmonary disease
- Refusal to participate
- Missing intraoperative ventilatory data
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 |
|---|---|---|
| Intraoperative Mechanical Ventilation MonitoringProspective recording of ventilatory parameters and respiratory mechanics during robotic surgery under general anesthesia. Measurements will be obtained at predefined surgical phases (after intubation, pneumoperitoneum initiation, steep Trendelenburg positioning, undocking, and before extubation). Recorded parameters include tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, arterial blood gas measurements, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index. | Other | Robotic Surgery |
Primary outcome
Ventilation Efficiency Index (VEI) change across robotic surgery phases
Time frame: Intraoperative (T0-T4)
Evaluation of VEI changes between predefined intraoperative phases.
2 secondary outcomes
Mechanical Power Change
Time frame: intraoperative
Static Lung Compliance Change
Time frame: intraoperative
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 16 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgery, run by Ankara City Hospital Bilkent 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 4 inclusion and 3 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 16 Jun 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?
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?
Ventilation Efficiency Index (VEI) change across robotic surgery phases (time frame: Intraoperative (T0-T4)). 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 16 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.