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Electrical Impedance TomographyPEaRLNCT07289113

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

A study testing 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 in people with Electrical Impedance Tomography, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Electrical Impedance Tomography
What is being tested?
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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteItaly
Study dates
12 Jan 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • scheduled for laparoscopic abdominal surgery
  • informed consent signed

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luigi Guglielmetti, MD contact

Italy1 site, 1 recruiting
  • Department of Anesthesia and Intensive Care Medicine

    Milan, Lombardy, 20154

    Tommaso Fossali, MD, +393282194697

    Recruiting

Other trials in Italy

About this study

Official title: Personalized PEEP Titration Guided by Electrical Impedance Tomography in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial - The PEaRL Study

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.

Read more

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.

Read the detailed description

Laparoscopic surgery has become an increasingly widespread surgical approach due to its minimally invasive nature, which allows for reduced postoperative pain, shorter hospital stays, and faster functional recovery compared to traditional open surgery. However, despite these advantages, laparoscopic procedures are not free from postoperative respiratory complications, which remain among the leading causes of postoperative morbidity. The combination of general anesthesia, the Trendelenburg position, and insufflation of CO₂ into the abdominal cavity can alter respiratory mechanics, reduce total lung capacity, and promote the development of atelectatic areas, resulting in impaired gas exchange (1-2).

Positive end-expiratory pressure (PEEP) is a widely used strategy to prevent alveolar collapse and improve oxygenation during mechanical ventilation. Nevertheless, the application of a standardized, non-individualized PEEP level may not be optimal for all patients, and an inappropriate PEEP setting may lead to alveolar overdistension or persistence of collapsed areas (3). Recently, personalized PEEP titration has gained attention as a method to tailor ventilation settings to individual patient characteristics, thereby minimizing the risk of ventilator-induced lung injury (VILI) (4).

Electrical Impedance Tomography (EIT) is a non-invasive, bedside imaging technique that enables real-time assessment of the regional distribution of pulmonary ventilation. EIT allows continuous monitoring of the effects of PEEP on both ventilated and non-ventilated lung regions and can guide the optimization of individualized PEEP levels to improve ventilation distribution and reduce the risk of respiratory complications (5-6). Recent studies have shown that the use of EIT-guided PEEP personalization in patients undergoing major surgery can improve respiratory parameters and reduce atelectasis formation (7-8). Specifically, EIT enables the performance of a PEEP trial, during which the device identifies areas of alveolar overdistension or collapse in response to PEEP changes, thereby guiding personalized ventilatory settings.

However, the application of this technique in the context of laparoscopic surgery remains limited. This study aims to evaluate the effectiveness of EIT-guided PEEP personalization in patients undergoing laparoscopic and robotic procedures, with the goal of improving regional ventilation, respiratory system compliance, and intraoperative gas exchange, as well as postoperative pulmonary function.

Being tested
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
Keywords
PEEP, Electrical Impedance Tomography, Laparoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07289113
Study groupRoleWhat they receive
Standard PEEPNo interventionPEEP value will be decided by clinician
EIT PEEPExperimentalPEEP value will be set after a PEEP trial performed with EIT machine
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: - 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start12 Jan 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07289113
Sponsor's protocol ID
CET 341-2025
Acronym
PEaRL
Status last verified
Jun 2026
First submitted
19 Nov 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37789753
  • 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.

    PubMed 38068519
  • 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.

    PubMed 38278058
  • 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.

    PubMed 38180544
  • 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.

    PubMed 39580405
  • 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.

    PubMed 39969340
  • 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.

    PubMed 40518045

Questions about this trial

What is this clinical trial studying?

A study testing 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 in people with Electrical Impedance Tomography, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tommaso Fossali (+393282194697, fossali.tommaso@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static respiratory system compliance (time frame: - 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07289113, which also lists 7 linked publications.

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 4 Jun 2026.

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