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

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04605133
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS, Human	Device: Electrical impedance tomography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine		Italy	33100

Sponsors and Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.

• Responsible Party: Luigi Vetrugno, Clinical Professor in Anesthesiology and Intensive Care, Azienda Sanitaria-Universitaria Integrata di Udine
• ClinicalTrials.gov Identifier: NCT04605133
• Other Study ID Numbers: EIT during pronation in ARDS
• First Posted: Oct 27, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Jul 21, 2021