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Clinical Trials/NCT04605133
NCT04605133
Unknown
Not Applicable

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

Azienda Sanitaria-Universitaria Integrata di Udine1 site in 1 country15 target enrollmentJune 1, 2020
ConditionsARDS, Human

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine
Enrollment
15
Locations
1
Primary Endpoint
Pronation and Regions of Interest increase in percentage
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Azienda Sanitaria-Universitaria Integrata di Udine

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

Outcomes

Primary Outcomes

Pronation and Regions of Interest increase in percentage

Time Frame: 1 hour after supination

Demonstrate that pronation, without any recruitment maneuver, augments the dorsal regions of interest of 5%.

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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