About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Electrical Impedance Tomography (EIT)-Guided Lung Recruitment
DeviceStaircase Recruitment Maneuver
Treatment groups
Trial outcomes
Primary outcomes
Global Inhomogeneity Index (GI)
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
Differences in Tidal Impedence
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.
Centre of Ventilation (CoV)
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.
Changes in Regional Ventilation Delay (RVD) Index
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
Partitioned Respiratory Mechanics
Chest wall and lung elastance, measured by esophageal pressure monitorin
Sponsors and contacts
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