NCT07402174

EIT- Guided Lung Recruitment in pARDS

EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 1 Month – 10 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	Electrical Impedance Tomography (EIT)-Guided Lung Recruitment	Staircase Recruitment Maneuver

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

2 sites across 1 country: Italy