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.

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.

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

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.

Beginning 6 months after publication; available for up to 2 years.

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.

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.