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

NCT04605133 | Unknown

• 1 other identifier: EIT during pronation in ARDS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio

  1 hour after supination

• Homogeneity of the ventral and dorsal regions from 0 to 1

  1 hour after supination

• Region of Interest ratio and days of mechanical ventilation.

  30 days after pronation

• Region of Interest ratio and length of stay in intensive care unit

  30 days after pronation

Study Arms (1)

ARDS

Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation

Device: Electrical impedance tomography

Interventions

Electrical impedance tomography DEVICE

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

ARDS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 25985386 BACKGROUND

• 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.

  PMID: 26397017 BACKGROUND

• 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.

  PMID: 27400909 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 27, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

IT (1)