Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress Syndrome, EIT, Children
Brief 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.
Interventions
DEVICEElectrical Impedance Tomography (EIT)-Guided Lung Recruitment
Staircase Recruitment Maneuver
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a physiological, exploratory study involving real-time monitoring of ventilation using electrical impedance tomography (EIT). Masking is not applicable because the intervention, namely EIT-guided lung recruitment, requires direct observation and real-time adjustment by clinicians based on EIT data. Therefore, no participants, care providers, investigators, or outcome assessors are masked.
Eligibility
Sex/Gender
ALL
Age
1 Months to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Inhomogeneity Index (GI) | Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Differences in Tidal Impedence | Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery | 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) | Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery | 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 | Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery | 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. |
Countries
Italy
Contacts
CONTACTGiovanna Chidini, MD
CONTACTStefano Scalia Catenacci, MD
PRINCIPAL_INVESTIGATORGiovanna Chidini, MD
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Outcome results
None listed