Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

• Conditions: Acute Respiratory Failure; Acute Respiratory Distress Syndrome
• Interventions: Other: Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)

• Registration Number: NCT05198986
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Study Start: 2022-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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
• presence of pneumothorax and/or pulmonary emphysema
• recent (1 week) thoracic surgery
• presence of chest burns
• inclusion in other research protocols
• refusal of consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECMO Prone Position	Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)	After baseline assessment in supine position, patients will be positioned in prone position to assess modification of lung mechanics, aeration and hemodynamics

Primary Outcome Measures

Name	Time	Method
Driving Pressure	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 Outcome Measures

Name	Time	Method
Respiratory system compliance	30 minutes after the prone positioning	Driving pressure to the tidal volume ratio
Cardiac output	30 minutes after the prone positioning	Liters of blood flow ejected from the heart per minute, measured through a pulmonary artery catheter
Pulmonary arterial pressure	30 minutes after the prone positioning	pulmonary arterial pressure measured through a pulmonary artery catheter
End-Expiratory Lung Impedance	30 minutes after the prone positioning	Measurement of the end expiratory lung volume, as assessed by the electrical impedance tomography

Trial Locations

Locations (1)

Federico Longhini; 🇮🇹 Catanzaro, Italy