EIT- Guided Lung Recruitment in pARDS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Electrical Impedance Tomography (EIT)-Guided Lung Recruitment

    Device

    Staircase Recruitment Maneuver

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: EIT-Guided RecruitmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Secondary outcomes

1

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.

Time frame
Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
2

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.

Time frame
Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
3

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.

Time frame
Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Other outcomes

1

Partitioned Respiratory Mechanics

Chest wall and lung elastance, measured by esophageal pressure monitorin

Time frame
Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery

Sponsors and contacts

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