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Clinical Trials in Italy / NCT04460859
Recruiting Observational

RecruitmEnt Assessed by eleCtRical Impedance Tomography

NCT04460859 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2020-06-09
Last updated
2025-05-20

Condition(s) studied

Acute Respiratory Distress Syndrome (ARDS)

Investigational drug(s) / intervention(s)

Specific lung recruitment maneuvers

Specific lung recruitment maneuvers: Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.

Study summary

The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg) * Under continuous sedation with or without paralysis Exclusion Criteria: * Age \<18 years * Bronchopleural fistula * Pure COPD exacerbation * Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement) * Hemodynamic instability (Systolic BP \< 75 mmHg or MAP \< 60 mmHg despite vasopressors and/or heart rate \< 55 bpm) * Attending physician deems the transient application of high airway pressures to be unsafe

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Faculdade de Medicina da University São Paulo São Paulo Brazil Recruiting
St. Michael's Hospital Toronto Ontario Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Not Yet Recruiting
Vall d'Hebron University Hospital Barcelona Spain Recruiting

More Unity Health Toronto trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04460859 on ClinicalTrials.gov ↗ ← All trials in Italy