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

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04605133
• Other study ID #: EIT during pronation in ARDS
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Electrical impedance tomography
Every patient is monitored with electrical impedance tomograpy before, during and after prone position.

Locations

Country	Name	City	State
Italy	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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