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

• Conditions: ARDS, Human
• Interventions: Device: Electrical impedance tomography

• Registration Number: NCT04605133
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-27
• Primary Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARDS	Electrical impedance tomography	Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD; 🇮🇹 Udine, Italy