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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ARDS, Human
• Intervention / Treatment: Device: Electrical impedance tomography

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Italy
  • Udine, Italy, 33100
    • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients' anthropometric data were collected. Ventilation parameters, electric impedence tomography parameters and blood gas analysis values were collected four times: patient supine (T0), one hour after pronation (T1), sixteen hours after pronation (T2), one hour after supination (T3).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS; Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation	Device: Electrical impedance tomography; Every patient is monitored with electrical impedance tomograpy before, during and after prone position.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio	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.	1 hour after supination
Homogeneity of the ventral and dorsal regions from 0 to 1	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.	1 hour after supination
Region of Interest ratio and days of mechanical ventilation.	Understand if there is an association between ROI ratio and the days of mechanical ventilation.	30 days after pronation
Region of Interest ratio and length of stay in intensive care unit	Understand if there is an association between ROI ratio and the length of stay in intensive care unit.	30 days after pronation

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

General Publications

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
• Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
• Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.
• Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (ACTUAL): October 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: EIT during pronation in ARDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No