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Clinical Trials/NCT05198986
NCT05198986
Unknown
Not Applicable

Effects of Pronation on Respiratory System Mechanical Properties and Ventilation in Patients With Acute Respiratory Distress Syndrome During Vv-ecmo

University Magna Graecia1 site in 1 country15 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
University Magna Graecia
Enrollment
15
Locations
1
Primary Endpoint
Driving Pressure
Last Updated
4 years ago

Overview

Brief Summary

The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications.

In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
February 28, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Magna Graecia
Responsible Party
Principal Investigator
Principal Investigator

Federico Longhini

Prof

University Magna Graecia

Eligibility Criteria

Inclusion Criteria

  • all adult patients with a diagnosis of severe Acute Respiratory Distress Syndrome receiving veno-venous ECMO

Exclusion Criteria

  • mechanical ventilation for 7 days or longer
  • pregnancy
  • body mass index (BMI) \> 45 kg/m2
  • chronic respiratory failure with long-term oxygen therapy or domiciliary non-invasive ventilation
  • cardiac failure resulting in veno-arterial ECMO
  • history of heparin- induced thrombocytopenia
  • cancer with a life expectancy of less than 5 years
  • moribund condition or a Simplified Acute Physiology Score (SAPS-II) value of more than 90;
  • current non drug- induced coma after cardiac arrest or presence of an irreversible neurologic injury
  • decision to withhold or withdraw life--sustaining therapies

Outcomes

Primary Outcomes

Driving Pressure

Time Frame: 30 minutes after the prone positioning

Difference between the airway plateau pressure and the total positive end-expiratory pressure after an inspiratory and expiratory hold maneuvers, respectively

Secondary Outcomes

  • Respiratory system compliance(30 minutes after the prone positioning)
  • Cardiac output(30 minutes after the prone positioning)
  • Pulmonary arterial pressure(30 minutes after the prone positioning)
  • End-Expiratory Lung Impedance(30 minutes after the prone positioning)

Study Sites (1)

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