EIT- Guided Lung Recruitment in pARDS (REMAV-EIT)

EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome

Study Title:

EIT-Guided Lung Recruitment Maneuvers in Pediatric ARDS: Effects on Ventilation Distribution and Respiratory Mechanics

Study Objective:

The primary goal of this clinical trial is to determine whether lung recruitment maneuvers guided by Electrical Impedance Tomography (EIT) result in a more homogeneous ventilation distribution and less injurious ventilation in children with pediatric Acute Respiratory Distress Syndrome (pARDS). The study will assess changes in intrapulmonary gas distribution and respiratory mechanics during recruitment maneuvers using both EIT and partitioned respiratory mechanics.

This is a prospective cohort study involving children diagnosed with pARDS. Eligible participants will be consecutively enrolled over time and will undergo a standardized series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be individualized and titrated based on the EIT-derived response to recruitment.

Main Research Questions:

How can lung recruitment maneuvers be performed safely in children with pARDS? How can we monitor the physiological effects of recruitment on respiratory mechanics? How does recruitment influence the distribution of ventilation within the lungs?

Eligible participants will undergo a series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be titrated and individualized based on the EIT-derived response to recruitment.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Electrical Impedance Tomography (EIT)-Guided Lung Recruitment

Detailed Description

This is a prospective, single-center, interventional physiological study aiming to assess the effects of EIT-guided lung recruitment maneuvers on ventilation distribution and respiratory mechanics in children with pediatric acute respiratory distress syndrome (pARDS).

A total of 8 mechanically ventilated children diagnosed with moderate-to-severe pARDS will be enrolled within 48 hours from intubation. All patients will undergo a standardized staircase recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT will be used to assess regional ventilation distribution and guide the titration of PEEP to minimize lung collapse and overdistension. Partitioned respiratory mechanics will be measured through esophageal pressure monitoring to assess changes in lung and chest wall compliance, as well as transpulmonary pressure.

Primary outcome is the change in global inhomogeneity index (GI Index) measured before and after recruitment. Secondary outcomes include center of ventilation (CoV), regional ventilation delay (RVD).

Will also considerd overdistension and collapse percentages, changes in lung/chest wall mechanics.

This pilot study will provide physiological data to inform the design of future randomized trials on EIT-guided mechanical ventilation strategies in pediatric ARDS.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanna Chidini, MD; Phone Number: 0039-2-55032242; Email: giovanna.chidini@policlinico.mi.it
• Study Contact Backup: Name: Stefano Scalia Catenacci, MD; Phone Number: 0039-2-55032242; Email: stefano.scaliacatenacci@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Italy
    • Milan, Italy, Italy, 20100
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Principal Investigator: Giovanna Chidini, MD
      • Contact: Virginia Figgiaconi, MD; Phone Number: 0039-2-55032242; Email: virginia.figggiaconi@policlinico.mi.it
      • Contact: Mario Madeo, Senior Nurse; Phone Number: 0039-2-55032241; Email: mario.madeo@policlinico.mi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged between 1 month and 10 years
• Diagnosis of pediatric Acute Respiratory Distress Syndrome (pARDS) according to PALICC-2 criteria
• Invasive mechanical ventilation for less than 48 hours at the time of enrollment

Exclusion Criteria:

• Evidence or history of barotrauma (e.g., pneumothorax, pneumomediastinum)
• Presence of congenital heart disease with hemodynamic significance
• Known or suspected intracranial hypertension
• Presence of an implantable cardioverter-defibrillator (ICD)
• Parental o legal guardian refuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EIT-Guided Recruitment; This arm includes all participants undergoing a standardized staircase lung recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT is used to assess regional ventilation distribution and guide the titration of PEEP. Mechanical ventilation settings are adjusted based on individual EIT-derived responses. Respiratory mechanics, including transpulmonary pressure and compliance partitioning, are also recorded to evaluate physiological effects of recruitment.

Device: Electrical Impedance Tomography (EIT)-Guided Lung Recruitment; Staircase Recruitment Maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Inhomogeneity Index (GI)	The Global Inhomogeneity Index (GI) is an EIT-derived quantitative measure of ventilation distribution heterogeneity across the lungs. A lower GI index indicates more homogeneous ventilation. GI will be calculated before and after the EIT-guided recruitment maneuver to assess the effect on regional ventilation distribution.	Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Tidal Impedence	Tidal impedance is a parameter derived from electrical impedance tomography (EIT) that reflects the regional distribution of ventilation during a tidal breath. Changes in electrical impedance measured between end-expiration and end-inspiration are proportional to changes in lung air volume, allowing real-time, bedside assessment of ventilation distribution.	Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Centre of Ventilation (CoV)	The centre of ventilation is a quantitative measure that describes the geometric mean location of tidal ventilation within the lung along a predefined axis, most commonly the ventral-dorsal or cranio-caudal axis.	Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Changes in Regional Ventilation Delay (RVD) Index	The RVD index quantifies the delay in regional ventilation during tidal breathing, indicating the degree of tidal recruitment or delayed filling. It reflects regional mechanical heterogeneity and is expected to decrease after effective lung recruitment.	Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partitioned Respiratory Mechanics	Chest wall and lung elastance, measured by esophageal pressure monitorin	Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Giovanna Chidini, MD, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021.
• Ren H, Xie L, Wang Z, Tang X, Ning B, Teng T, Qian J, Wang Y, Fu L, Zhao Z, Xiang L. Comparison of Global and Regional Compliance-Guided Positive End-Expiratory Pressure Titration on Regional Lung Ventilation in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2022 May 23;9:805680. doi: 10.3389/fmed.2022.805680. PMID: 35677825; PMCID: PMC9167956.
• Cabezudo Ballesteros S, Sanabria Carretero P, Reinoso Barbero F. Review of electrical impedance tomography in the pediatric patient. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jun-Jul;71(6):479-485. doi: 10.1016/j.redare.2024.03.007. Epub 2024 Mar 6. PMID: 38458492.
• Soltész L, Leyens J, Vogel M, Muders T, Putensen C, Kipfmueller F, Dresbach T, Mueller A, Schroeder L. EIT guided evaluation of regional ventilation distributions in neonatal and pediatric ARDS: a prospective feasibility study. Respir Res. 2025 Feb 19;26(1):60. doi: 10.1186/s12931-025-03134-8. Erratum in: Respir Res. 2025 Jun 4;26(1):208. doi: 10.1186/s12931-025-03292-9. PMID: 39972380; PMCID: PMC11841312.
• Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z. PMID: 37046213; PMCID: PMC10091533.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Acute Respiratory Distress Syndrome; EIT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: 1170_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD), including respiratory mechanics and EIT-derived ventilation metrics, will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results and following approval by the principal investigator and ethics committee.
• IPD Sharing Time Frame: Beginning 6 months after publication; available for up to 2 years.
• IPD Sharing Access Criteria: Researchers must submit a methodologically sound proposal and obtain approval from the principal investigator. In accordance with institutional policy, a formal Data Transfer Agreement (DTA) approved by the hospital's research foundation will be required before any data can be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No