Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children

NCT07319624 | Completed

• 1 other identifier: PETI
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age. This population is challenging for its variety and anatomophysiologic peculiarity. A decremental PEEP trial using 1 cmH₂O steps following a recruitment maneuver at 35 cmH₂O was compared between EIT and other best PEEP assessment protocols.

Conditions

Pneumonia; Tetralogy of Fallot Correction; Caustics Ingestion; Orthotopic Liver Transplantation

Keywords

EIT; PEEP; Mechanical Ventilation; Electrical Impedence Tomography; PARDS

Outcome Measures

Primary Outcomes (1)

• Feasibility (% of patients that complete the EIT-guided PEEP trial)

  assessing the feasibility of an individualized PEEP titration using an EIT-guided decremental PEEP trial specifically designed for smaller children.

  20 weeks

Secondary Outcomes (5)

• To compare PEEPeit (cmH2O) with PEEPnih (cmH2O)

  20 weeks

• To evaluate changes of EIT patterns of overdistension (%) and derecruitment (%) according to changes in respiratory system Compliance-guided method (mL/cmH2O)

  20 weeks

• To assess changes in respiratory system compliance (mL/cmH2O) across different PEEP levels (cmH2O)

  20 weeks

• To assess changes in end-expiratory lung impedance (arbitrary units) by EIT across different PEEP levels (cmH2O)

  20 weeks

• To assess changes in oxygenation (PaO2/FiO2, mmHg) across different PEEP levels

  20 weeks

Study Arms (1)

Pediatric Acute Respiratory Distress Syndrome (PARDS) patients

EXPERIMENTAL

Patients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics.

Diagnostic Test: Electrical Impedence Tomography

Interventions

Electrical Impedence Tomography DIAGNOSTIC_TEST

An EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the children's weight was placed at the fourth or fifth intercostal space along the axillary line.

Pediatric Acute Respiratory Distress Syndrome (PARDS) patients

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age under 3
• Impaired oxygenation - defined as an
• oxygenation Index (OI = mean airway pressure multiplied by FiO₂ divided by PaO₂) greater than 4; and/or
• an Oxygen Saturation Index (OSI = mean airway pressure multiplied by FiO₂ divided by SpO₂) greater than 5; or
• altered respiratory mechanics - defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.

You may not qualify if:

• thoracic fractures
• chest drains
• subcutaneous thoracic devices
• presence of intracardiac shunts
• confirmed or suspected pneumothorax on chest X-ray or lung ultrasound
• hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers.
• technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability
• belt-to-chest size incompatibility (\< 3 kg)
• lack of informed consent

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Papa Giovanni XXIII Hospital, Bergamo, BG 24100

Bergamo, Italy, 24100, Italy

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alfio Bronco, MD

  Papa Giovanni XXIII Hospital, Bergamo, BG 24100

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Consultant Pediatric Intensivist

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 6, 2026
• Study Start: December 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

IT (1)