NCT07402174

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

June 11, 2025

Last Update Submit

February 3, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress SyndromeEITChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Differences in Tidal Impedence

    Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

  • Centre of Ventilation (CoV)

    Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

  • Changes in Regional Ventilation Delay (RVD) Index

    Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Other Outcomes (1)

  • Partitioned Respiratory Mechanics

    Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Study Arms (1)

EIT-Guided Recruitment

EXPERIMENTAL

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

Interventions

Electrical Impedance Tomography (EIT)-Guided Lung RecruitmentDEVICE

Staircase Recruitment Maneuver

EIT-Guided Recruitment

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy, 20100, Italy

Location

Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

  • 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.

    PMID: 11511953BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Giovanna Chidini, MD

    Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Chidini, MD

CONTACT

0039-2-55032242giovanna.chidini@policlinico.mi.it

Stefano Scalia Catenacci, MD

CONTACT

0039-2-55032242stefano.scaliacatenacci@policlinico.mi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is a physiological, exploratory study involving real-time monitoring of ventilation using electrical impedance tomography (EIT). Masking is not applicable because the intervention, namely EIT-guided lung recruitment, requires direct observation and real-time adjustment by clinicians based on EIT data. Therefore, no participants, care providers, investigators, or outcome assessors are masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2025

First Posted

February 11, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 11, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months after publication; available for up to 2 years.
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.
More information

Locations

IT(2)