Evaluating Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

NCT06540794 | Enrolling By Invitation

• 1 other identifier: 020724-982717
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Lung Protective Ventilation; Postoperative Pulmonary Complications

Keywords

driving pressure; electrical impedance tomography; robot assisted laparoscopic prostatectomy; peep titration; recruitment

Outcome Measures

Primary Outcomes (1)

• ROI and GI index

  The ROI values measured by electrical impedance tomography for all patients were recorded before intubation, immediately after intubation, at the 15th, 60th, and 120th minutes of pneumoperitoneum and Trendelenburg position, before extubation in the supine position, and 5 minutes after extubation. The GI index values, calculated using mathematical software with the EIT values recorded on the computer, were recorded before intubation, immediately after intubation, before extubation in the supine position, and 5 minutes after extubation.

  peroperative

Secondary Outcomes (1)

• POSTOPERATIVE PULMONARY COMPLICATIONS

  up to 2 days following surgery

Study Arms (2)

Group sPEEP (standard positive end-expiratory pressure)

NO INTERVENTION

Patients in this group will receive mechanical ventilation with a PEEP value of 5 cmH2O, following the recruitment maneuver.

Group kPEEP (personalized positive end-expiratory pressure)

EXPERIMENTAL

A decremental PEEP titration strategy will be chosen after recruitment to determine the PEEP value that provides the lowest driving pressure. The personalized PEEP value (kPEEP) that provides the lowest driving pressure will be measured and maintained throughout the mechanical ventilation period. To find this value, the PEEP level will first be set at 15 cmH2O and maintained for 12 breathing cycles, after which the driving pressure will be recorded. Subsequently, the PEEP level will be decreased by 1 cmH2O and maintained for 12 breathing cycles, with the driving pressure recorded at each level. This strategy will continue until the PEEP level reaches 5 cmH2O. During these measurements, the tidal volume will be set at 8 ml/kg, the respiratory rate at 12 breaths/min, and the inspiratory: expiratory ratio at 1:2. The PEEP value that provides the lowest driving pressure will be recorded as kPEEP and maintained during pneumoperitoneum.

Other: PEEP TITRATION

Interventions

PEEP TITRATION OTHER

Determining the optimal PEEP value that provides the lowest driving pressure using decremental PEEP titration.

Group kPEEP (personalized positive end-expiratory pressure)

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who underwent surgery requiring mechanical ventilation for more than 1 hour within 2 weeks before the operation
• Patients with a body mass index over 35
• Patients with large bullae or pneumothorax, those currently receiving oxygen support, those with severe respiratory disease
• 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
• Patients who refused to participate in the study were excluded.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University- Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Anesthesiology and Reanimation

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ezgi B Ozyalcın, Medical Doctor

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: July 16, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-07

Locations

TU (1)