Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04605133

Enrollment

Registered

2020-10-27

Start date

2020-06-01

Completion date

2021-12-31

Last updated

2021-07-21

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

Conditions

ARDS, Human

Brief summary

Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.

Interventions

DEVICEElectrical impedance tomography

Every patient is monitored with electrical impedance tomograpy before, during and after prone position.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* mild or severe ARDS according to Berlin's Criteria * recruitment maximum 72 hours from the diagnosis of ARDS

Exclusion criteria

* other non-ARDS respiratory system pathologies * hemodynamic instability (mean arterial pressure \< 60 mmHg) * pneumothorax * endocranial hypertension * skin lesions or burns * presence of pacemaker or implantable defibrillator * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Pronation and Regions of Interest increase in percentage	1 hour after supination	Demonstrate that pronation, without any recruitment maneuver, augments the dorsal regions of interest of 5%.

Secondary

Measure	Time frame	Description
PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio	1 hour after supination	Obtain a statistical significant increase of PaO2/FiO2 ratio, with a consensual decrease of the ventral/dorsal Region of Interest ratio. It'a a measure of the difference between two ratios.
Homogeneity of the ventral and dorsal regions from 0 to 1	1 hour after supination	Verify in which of the 4 measurements (T0-T1-T2-T3) the ventral/dorsal Region of Interest ratio is closer to 1, which means a complete homogeneity of the ventral and dorsal regions.
Region of Interest ratio and days of mechanical ventilation.	30 days after pronation	Understand if there is an association between ROI ratio and the days of mechanical ventilation.
Region of Interest ratio and length of stay in intensive care unit	30 days after pronation	Understand if there is an association between ROI ratio and the length of stay in intensive care unit.

Countries

Italy

Outcome results

None listed

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