REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

Study Overview
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Brief Summary
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There is evidence from randomized controlled trials in adult patients with Acute Respiratory Distress Syndrome (ARDS) suggesting that delivering small tidal volumes with adequate levels of Positive End-Expiratory Pressure (PEEP) and a restrictive fluid strategy could improve outcome. However, there are data and common bedside experience that individual patients may or may not respond to interventions, such as escalation of PEEP or positional changes, and there may be a role for a more personalized ventilator strategy. This strategy could account for the unique individual morphology of lung disease, such as the amount of atelectasis and overdistension as a percentage of total lung tissue, the exact location of atelectasis, and whether positional changes or elevation of PEEP produce lung recruitment or overdistension. Stepwise Recruitment maneuvers (SRMs) in pARDS improve oxygenation in majority of patients. SRMs should be considered for use on an individualized basis in patients with pARDS should be considered if SpO2 decreases by ≥ 5% within 5 minutes of disconnection during suction or coughing or agitation. If a recruitment maneuver is conducted, a decremental PEEP trial must be done to determine the minimum PEEP that sustains the benefits of the recruitment maneuver. Electrical impedance tomography (EIT), a bedside monitor to describe regional lung volume changes, displays a real-time cross-sectional image of the lung. EIT is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable. It allows to study ventilation distribution dividing lungs in four Region Of Interest (ROI), that are layers distributed in an anteroposterior direction, and shows how ventilation is distributed in the areas concerned. EIT measures and calculates other parameters that are related not only to the distribution of ventilation, but also to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as SRMs or PEEP-application. Aim of this study is to provide a protocolized strategy to assess optimal recruitment and PEEP setting, tailored on the patients individual response in pARDS.

Official Title
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REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)

Conditions
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ARDS, Pediatric Respiratory Distress Syndrome, Respiratory Disease

Intervention / Treatment
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* Device: EIT measurement
* Device: Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial
* Device: Setting of EIT-guided mechanical ventilation
* Device: Reevaluation after 24 h


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intubated and mechanically ventilated children, ageing 1 months-5 years and meeting the PALICC definition for pediatric Acute Respiratory Distress Syndrome (pARDS) Informed Consent signed Exclusion Criteria: Patients with one or more of the following characteristics: Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema) Signs of intracranial hypertension Cyanotic congenital cardiac disease Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis) Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator) Controindication to positioning the esophageal catheter (surgery, esophageal stenosis)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T0= Enrollment<br>mechanical ventilation will be set according to the standard of care criteria | Device: EIT measurement<br>* Evaluation of mechanical ventilation and ventilation distribution through EIT. Mechanical ventilation is set by the physician according to clinical protocolized criteria<br>|
| Active Comparator: T1= guided MV at the end of SRM trial<br>EIT guided mechanical ventilation will be set | Device: Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial<br>* SRMs will be performed with a standardized ventilation protocol. Patient will be sedated, paralyzed and ventilated in pressure controlled mode, FIO2 to obtain SPO2> 92%, RR 25, I:E =1:1.5. Alarm of pressure limit will be set at 35 cmH2O. The ventilator will be equipped with inspiratory and expiratory hold taste. Inspiratory and expiratory occlusion will be held for 5 seconds, data will be stored and analyzed with the ventilator own tool. Decremental PEEP trial will start if plateau pressure 30 cmH2O will be reached or end inspiratory transpulmonary pressure will exceed 28 cmH2O value. Once reached this level of plateau or transpulmonary pressure, PEEP will be reduced in three steps from 12, 10 and finally to 8 cmH2O every 20 minutes<br>* Other names: SRMs EIT-guided and DP trial;Device: Setting of EIT-guided mechanical ventilation<br>* Mechanical ventilation is set according to EIT measurement<br>|
| Active Comparator: T2= 24 hours with EIT guided MV<br>evaluation of mechanical ventilation after 24h EIT-guided ventilation | Device: Reevaluation after 24 h<br>* Evaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Ventilation Delay, RDV (pixels %), at T2 and T0 | RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2 | for every breathing cycle, a so-called tidal image is generated and each pixel of represents the difference in impedance between end-inspiration and end-expiration. The median value of each tidal image is calculated for the lung area | 1 day | 
| Gravity Centre, GC, differences (pixels %) at T0, T1 and T2 | it is the weighted mean of row sums obtained from TV image and it indicates ventral-to-dorsal shifts in ventilation distribution due to lung opening and closing | 1 day | 
| Respiratory Rate at T0, T1 and T2 | Respiratory rate (breaths/min) | 1 day | 
| FiO2 (%) at T0, T1 and T2 | FiO2 (%) | 1 day | 
| Respiratory compliance at T0, T1 and T2 | Respiratory System Compliance | 1 day | 
| Lung compliance at T0, T1 and T2 | Clung Lung compliance | 1 day | 
| Chest Wall compliance at T0, T1 and T2 | Chest Wall compliance | 1 day | 
| S/F ratio at T0, T1 and T2 | S/F ratio | 1 day | 
| Sistolic Blood Pressure at T0, T1 and T2 | SBP (mmHg) | 1 day | 
| Diastolic Blood Pressure at T0, T1 and T2 | DBP (mmHg) | 1 day | 
| pH at T0, T1 and T2 | pH | 1 day | 
| SpO2 at T0, T1 and T2 | SpO2 (%) | 1 day | 
| PaO2 at T0, T1 and T2 | PaO2 (mmHg) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non invasive ventilation, electrical impedance tomography;