PEEP Titration Guided by Electrical Impedance Tomography in Laparoscopic Surgery The PEaRL Study

NCT07289113 | Not Yet Recruiting

• 1 other identifier: CET 341-2025
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Laparoscopic surgery has gained widespread adoption due to its minimally invasive nature, offering advantages such as reduced postoperative pain, shorter hospitalization, and faster functional recovery compared with traditional open surgery. Nevertheless, postoperative respiratory complications remain a major source of morbidity. Factors such as general anesthesia, the Trendelenburg position, and CO₂ pneumoperitoneum can impair respiratory mechanics, reduce total lung capacity, and promote atelectasis, leading to compromised gas exchange. Rationale: Positive end-expiratory pressure (PEEP) is routinely applied to prevent alveolar collapse and improve oxygenation during mechanical ventilation. However, the use of standardized, non-individualized PEEP levels may be suboptimal, as inappropriate settings can cause alveolar overdistension or persistent collapse. Personalized PEEP titration, tailored to patient-specific lung mechanics, has recently emerged as a promising strategy to minimize ventilator-induced lung injury (VILI). Methods and Tools: Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring technique that enables real-time assessment of regional lung ventilation. By evaluating ventilated and non-ventilated lung areas, EIT can guide PEEP optimization and support individualized ventilatory management. Recent studies suggest that EIT-guided PEEP titration improves respiratory parameters and reduces atelectasis in patients undergoing major surgery. Objective: The present study aims to evaluate the efficacy of EIT-guided PEEP personalization in patients undergoing laparoscopic and robotic surgery. Primary endpoints include improvements in regional ventilation, respiratory system compliance, and intraoperative gas exchange, as well as postoperative pulmonary function.

Conditions

Electrical Impedance Tomography

Keywords

PEEP; Electrical Impedance Tomography; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Static respiratory system compliance

  Respiratory system compliance is equivalent to tidal volume divided by the diiference between plateau and PEEP pressure. Unit of measurement is cmH2O/mL

  - Baseline (after anesthesia induction) - T1 (After Trendelemburg position and induction of pneumoperitoneum) - T2 (After PEEP trial) - T3 (90 minutes after PEEP trial) - T4 (180 minutes after PEEP trial) - T5 (Before end of anesthesia)

Study Arms (2)

Standard PEEP

NO INTERVENTION

PEEP value will be decided by clinician

EIT PEEP

EXPERIMENTAL

PEEP value will be set after a PEEP trial performed with EIT machine

Device: A PEEP trial performed with the PulmoVista® 500 (Dräger, Lübeck, Germany) is a procedure designed to identify the optimal level of positive end-expiratory pressure

Interventions

A PEEP trial performed with the PulmoVista® 500 (Dräger, Lübeck, Germany) is a procedure designed to identify the optimal level of positive end-expiratory pressure DEVICE

During the trial, stepwise adjustments of PEEP are made while EIT provides real-time, bedside visualization of ventilation distribution across different lung regions. Typically, the protocol involves a recruitment maneuver followed by incremental and/or decremental PEEP steps (for example, in 2-3 cmH₂O intervals). At each step, EIT measures changes in regional impedance, which reflect variations in local lung aeration and ventilation. By analyzing these parameters, clinicians can determine the individualized "best PEEP", defined as the point at which alveolar collapse is minimized without causing significant overdistension. The optimal PEEP is then set for subsequent ventilation management.

EIT PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for laparoscopic abdominal surgery
• informed consent signed

You may not qualify if:

• COPD
• Acute respiratory failure
• Hemodynamic instability
• Pregnancy
• Contraindications for EIT device

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Related Publications (7)

• Ma X, Fu Y, Piao X, De Santis Santiago RR, Ma L, Guo Y, Fu Q, Mi W, Berra L, Zhang C. Individualised positive end-expiratory pressure titrated intra-operatively by electrical impedance tomography optimises pulmonary mechanics and reduces postoperative atelectasis: A randomised controlled trial. Eur J Anaesthesiol. 2023 Nov 1;40(11):805-816. doi: 10.1097/EJA.0000000000001901. Epub 2023 Sep 13.

  PMID: 37789753 RESULT

• Rauseo M, Spadaro S, Mirabella L, Cotoia A, Laforgia D, Gaudino G, Vinella F, Ferrara G, Gattullo A, Tullo L, Cinnella G. Electrical Impedance Tomography during Abdominal Laparoscopic Surgery: A Physiological Pilot Study. J Clin Med. 2023 Dec 1;12(23):7467. doi: 10.3390/jcm12237467.

  PMID: 38068519 RESULT

• Jiang L, Deng Y, Xu F, Qiao S, Wang C. Individualized PEEP guided by EIT in patients undergoing general anesthesia: A systematic review and meta-analysis. J Clin Anesth. 2024 Jun;94:111397. doi: 10.1016/j.jclinane.2024.111397. Epub 2024 Jan 25.

  PMID: 38278058 RESULT

• Pavlovsky B, Desprez C, Richard JC, Fage N, Lesimple A, Chean D, Courtais A, Mauri T, Mercat A, Beloncle F. Bedside personalized methods based on electrical impedance tomography or respiratory mechanics to set PEEP in ARDS and recruitment-to-inflation ratio: a physiologic study. Ann Intensive Care. 2024 Jan 5;14(1):1. doi: 10.1186/s13613-023-01228-4.

  PMID: 38180544 RESULT

• Gao Y, He H, Chi Y, Frerichs I, Long Y, Zhao Z. Electrical impedance tomography guided positive end-expiratory pressure titration in critically ill and surgical adult patients: a systematic review and meta-analysis. BMC Pulm Med. 2024 Nov 23;24(1):582. doi: 10.1186/s12890-024-03394-y.

  PMID: 39580405 RESULT

• Chen L, Yu K, Yang J, Han X, Liu L, Li T, Miao H. Electrical impedance tomography-guided positive end-expiratory pressure titration for perioperative oxygenation and postoperative pulmonary complications: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Dec 27;103(52):e40357. doi: 10.1097/MD.0000000000040357.

  PMID: 39969340 RESULT

• Scaramuzzo G, Priani P, Ferrara P, Verri M, Montanaro F, La Rosa R, Cammarota G, Volta CA, Spadaro S. Longitudinal changes of electrical impedance tomography-based best PEEP in obese patients undergoing laparoscopic surgery: A prospective physiological study. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101569. doi: 10.1016/j.accpm.2025.101569. Epub 2025 Jun 13.

  PMID: 40518045 RESULT

Study Officials

• Tommaso Fossali, MD

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Fossali

CONTACT

+393282194697; fossali.tommaso@asst-fbf-sacco.it

Luigi Guglielmetti, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, head of the anesthesiologists

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share