NCT06067152: REMAV-EIT

REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

Status unknown NA Last updated 4 October 2023

What this trial tests

NA trial testing EIT measurement in ARDS in 13 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
30 December 2023

30 January 2024

Quick facts

Lead sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	13
Start date	1 January 2022
Primary completion	30 December 2023
Estimated completion	30 January 2024
Sites	1 location across Italy

Drugs / interventions tested

• EIT measurement
• Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial
• Setting of EIT-guided mechanical ventilation
• Reevaluation after 24 h

Conditions studied

• ARDS — all drugs for ARDS →
• Pediatric Respiratory Distress Syndrome — all drugs for Pediatric Respiratory Distress Syndrome →
• Respiratory Disease — all drugs for Respiratory Disease →

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Who can join

Adults 1 Month to 5, any sex, with ARDS or Pediatric Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.