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NCT Number: NCT07402174

EIT- Guided Lung Recruitment in pARDS

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.

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Key information

Age range

1 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Impedance Tomography (EIT)-Guided Lung Recruitment

Device

Staircase Recruitment Maneuver

Primary outcomes

  1. Global Inhomogeneity Index (GI)

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

    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.

Secondary outcomes

  1. Differences in Tidal Impedence

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

    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.

  2. Centre of Ventilation (CoV)

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

    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.

  3. Changes in Regional Ventilation Delay (RVD) Index

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

    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.

Other outcomes

  1. Partitioned Respiratory Mechanics

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

    Chest wall and lung elastance, measured by esophageal pressure monitorin

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanna Chidini, MD

CONTACT

[email protected]

0039-2-55032242

Stefano Scalia Catenacci, MD

CONTACT

[email protected]

0039-2-55032242

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome

Acronym: REMAV-EIT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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