Clinical trial NCT04605133: Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
Official title: Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pronation and Regions of Interest increase in percentage
timeFrame: 1 hour after supination
Secondary outcomes:
measure: PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio
timeFrame: 1 hour after supination
measure: Homogeneity of the ventral and dorsal regions from 0 to 1
timeFrame: 1 hour after supination
measure: Region of Interest ratio and days of mechanical ventilation.
timeFrame: 30 days after pronation
measure: Region of Interest ratio and length of stay in intensive care unit
timeFrame: 30 days after pronation
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Study officials:
References:
citation: 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.
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.
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.
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.