NCT06540794Completed
Evaluating Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Evaluation of the Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
Robot-Assisted Laparoscopic Radical Prostatectomy is a method increasingly used for prostate cancer due to fewer complications, morbidity, and mortality compared to other methods. The technique involves inflating the abdomen with carbon dioxide to provide visualization and working in a steep Trendelenburg position, which puts pressure on the lungs and can cause them to collapse. The functional residual capacity reduction caused by general anesthesia, combined with the negative effects of the position, increases the risk of significant respiratory system complications during and after surgery. Lung protective ventilation strategies can reduce the incidence of postoperative pulmonary complications (PPC) by alleviating iatrogenic injury to previously healthy lungs. Apart from a low tidal volume (VT), applying positive end-expiratory pressure (PEEP) can minimize the risk of atelectasis and/or overdistension. There is limited information on how to adjust optimal PEEP under increased intra-abdominal pressure during laparoscopy. A meta-analysis study on acute respiratory distress syndrome (ARDS) patients showed that high driving pressure (plateau pressure - PEEP) is the most associated value with mortality. It was shown that VT, plateau pressure, and PEEP are not related to patient outcomes or only when they affect driving pressure. Subsequent retrospective and prospective studies confirmed the importance of driving pressure in ARDS patients and surgical patients. For patients under mechanical ventilation, applying a personalized PEEP that provides the lowest driving pressure, along with maneuvers to open closed alveoli (recruitment), reduces respiratory system complications during and after surgery. One method to visualize the effects of these maneuvers and the ideal PEEP application, which provides the lowest driving pressure for the patient, is electrical impedance tomography (EIT), a non-invasive, radiation-free bedside imaging technique. EIT, measured with 16 electrodes placed on an elastic belt around the patient\'s 4th to 6th ribs, shows impedance changes in the lungs. This method successfully visualizes and evaluates dynamic changes in gas distribution within the lungs and has been validated by computed tomography scans, proving safe for use in both adults and pediatric patients. EIT divides the lungs into four layers from ventral to dorsal, showing the percentage distribution of tidal volume in these regions. Examining the relative impedance changes allows for observing gas volume distribution entering the lungs and evaluating regional lung characteristics. Therefore, EIT can contribute to examining the PEEP value that ensures homogeneous gas distribution in the lungs and preventing ventilator-associated lung injury. The aim of our study is to evaluate the effect of driving pressure guided mechanical ventilation on lung gas distribution during robot-assisted laparoscopic radical prostatectomy through respiratory parameters recorded by EIT during surgery and perioperative period and to compare perioperative pulmonary complications with traditional ventilation methods
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 2 Aug 2024
- Start date
- 6 Aug 2024
- Primary completion date
- 23 Oct 2024
- Lead sponsor
- Istanbul University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT06540794
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 6 Aug 2024 to the primary completion date, 23 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who underwent surgery requiring mechanical ventilation for more than 1 hour within 2 weeks before the operation
- Patients with large bullae or pneumothorax, those currently receiving oxygen support, those with severe respiratory disease
Other illness
- Patients with severe heart failure classified as NYHA class III-IV by the New York Heart Association (NYHA), those with a pacemaker or cardiac defibrillator implant
- Patients with progressive neuromuscular disease
Other
- Patients with a body mass index over 35
- Patients who refused to participate in the study were excluded.
Who the study is looking for
- ASA score of I-II-III according to the American Society of Anesthesiologists (ASA) physical status classification system
- Surgery duration is expected to be longer than 2 hours
Age in the registry: - to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istanbul University- Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.