REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS
- Conditions
- Pediatric Respiratory Distress SyndromeARDSRespiratory Disease
- Interventions
- Device: EIT measurementDevice: Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trialDevice: Reevaluation after 24 hDevice: Setting of EIT-guided mechanical ventilation
- Registration Number
- NCT06067152
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 13
- 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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description T1= guided MV at the end of SRM trial Setting of EIT-guided mechanical ventilation EIT guided mechanical ventilation will be set T0= Enrollment EIT measurement mechanical ventilation will be set according to the standard of care criteria T1= guided MV at the end of SRM trial Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial EIT guided mechanical ventilation will be set T2= 24 hours with EIT guided MV Reevaluation after 24 h evaluation of mechanical ventilation after 24h EIT-guided ventilation
- Primary Outcome Measures
Name Time Method Regional Ventilation Delay, RDV (pixels %), at T2 and T0 1 day RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation
- Secondary Outcome Measures
Name Time Method FiO2 (%) at T0, T1 and T2 1 day FiO2 (%)
Respiratory compliance at T0, T1 and T2 1 day Respiratory System Compliance
Chest Wall compliance at T0, T1 and T2 1 day Chest Wall compliance
SpO2 at T0, T1 and T2 1 day SpO2 (%)
Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2 1 day 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
Lung compliance at T0, T1 and T2 1 day Clung Lung compliance
Sistolic Blood Pressure at T0, T1 and T2 1 day SBP (mmHg)
Diastolic Blood Pressure at T0, T1 and T2 1 day DBP (mmHg)
PaO2 at T0, T1 and T2 1 day PaO2 (mmHg)
Gravity Centre, GC, differences (pixels %) at T0, T1 and T2 1 day 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
Respiratory Rate at T0, T1 and T2 1 day Respiratory rate (breaths/min)
S/F ratio at T0, T1 and T2 1 day S/F ratio
pH at T0, T1 and T2 1 day pH
Trial Locations
- Locations (1)
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
🇮🇹Milan, Italy