Actively Recruiting
Led by ASST Fatebenefratelli Sacco · Updated on 2026-06-04
52
Participants Needed
1
Research Sites
4 weeks
Total Duration
Laparoscopic surgery is widely used because it is less invasive, leading to less pain after surgery, shorter hospital stays, and quicker recovery compared to traditional open surgery. However, patients undergoing these procedures still face risks of breathing problems after surgery due to factors like general anesthesia, body positioning during surgery, and the use of CO2 gas in the abdomen. This study explores using a personalized approach to setting positive end-expiratory pressure (PEEP), a ventilation technique that helps keep lungs open, guided by Electrical Impedance Tomography (EIT), to improve lung function during laparoscopic and robotic surgeries. Participants will be randomly assigned to one of two groups. One group will receive standard PEEP settings decided by clinicians, while the other group will have PEEP levels personalized using a PEEP trial guided by the PulmoVista® 500 EIT device. This device monitors lung ventilation in real time and helps find the best PEEP level to reduce lung collapse without causing overinflation. The personalized PEEP is adjusted during surgery and maintained throughout the procedure to optimize lung function. During the study, participants will be closely monitored at several time points, including before and after anesthesia induction, during surgery in specific positions, and after PEEP adjustments. Researchers will measure static respiratory system compliance, which reflects how well the lungs can expand, as the main outcome. The study will also observe gas exchange and lung function after surgery. The entire process aims to improve respiratory health during and after laparoscopic surgery while tracking safety and recovery progress, with the study concluding in November 2026.
CONDITIONS
PEEP Titration Guided by Electrical Impedance Tomography in Laparoscopic Surgery The PEaRL Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic abdominal surgery under general anesthesia.
1 surgical visit (in-person)
Duration - During surgery
Participants receive mechanical ventilation during surgery with PEEP settings either determined by clinician or personalized using an Electrical Impedance Tomography (EIT)-guided PEEP trial.
1 intraoperative visit (in-person) for PEEP titration and ventilation monitoring
Duration - Up to 3 hours after PEEP trial
Participants are monitored for respiratory function and possible postoperative pulmonary complications following surgery.
Several assessments during the first 180 minutes post-PEEP trial
Total: 1 location
1
Department of Anesthesia and Intensive Care Medicine
Milan, Lombardy, Italy, 20154
Actively Recruiting
T
Tommaso Fossali
L
Luigi Guglielmetti, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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