EIT- Guided Lung Recruitment in pARDS

Official title

EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome

Overview

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.

Interventions

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

Primary outcome measures

• Global Inhomogeneity Index (GI) [Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery]

Secondary outcome measures (3)

• Differences in Tidal Impedence [Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery]
• Centre of Ventilation (CoV) [Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery]
• Changes in Regional Ventilation Delay (RVD) Index [Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
• Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico — Milan

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. PMID 11511953
• 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. eCollection 2022. PMID 35677825
• 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
• Soltesz 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. PMID 39972380
• 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

Identifiers

NCT: NCT07402174 · 1170_2021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗