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REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06067152
Acronym
REMAV-EIT
Enrollment
13
Registered
2023-10-04
Start date
2022-01-01
Completion date
2024-01-30
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Pediatric Respiratory Distress Syndrome, Respiratory Disease

Keywords

Non invasive ventilation, electrical impedance tomography;

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.

Interventions

DEVICEEIT measurement

Evaluation of mechanical ventilation and ventilation distribution through EIT. Mechanical ventilation is set by the physician according to clinical protocolized criteria

DEVICEStaircase Recruitment Maneuvers with EIT guided and decremental PEEP trial

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

DEVICESetting of EIT-guided mechanical ventilation

Mechanical ventilation is set according to EIT measurement

DEVICEReevaluation after 24 h

Evaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Regional Ventilation Delay, RDV (pixels %), at T2 and T01 dayRDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation

Secondary

MeasureTime frameDescription
Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T21 dayfor 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
Gravity Centre, GC, differences (pixels %) at T0, T1 and T21 dayit 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
FiO2 (%) at T0, T1 and T21 dayFiO2 (%)
Respiratory compliance at T0, T1 and T21 dayRespiratory System Compliance
Lung compliance at T0, T1 and T21 dayClung Lung compliance
Chest Wall compliance at T0, T1 and T21 dayChest Wall compliance
Respiratory Rate at T0, T1 and T21 dayRespiratory rate (breaths/min)
Sistolic Blood Pressure at T0, T1 and T21 daySBP (mmHg)
Diastolic Blood Pressure at T0, T1 and T21 dayDBP (mmHg)
pH at T0, T1 and T21 daypH
SpO2 at T0, T1 and T21 daySpO2 (%)
PaO2 at T0, T1 and T21 dayPaO2 (mmHg)
S/F ratio at T0, T1 and T21 dayS/F ratio

Countries

Italy

Contacts

Primary ContactGiovanna Chidini, MD
giovanna.chidini@policlinico.mi.it0255032242
Backup ContactStefano Scalia-Catenacci, MD
stefani.scaliacatenacci@policlinico.mi.it0255032242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026