Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05198986
• Other study ID #: ECMO-PP
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2022
• Source: University Magna Graecia
• Contact: Federico Longhini, MD
• Phone: +393475395967
• Email: longhini.federico[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Syndrome

Intervention

Other:
• Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)
Pronation will be executed according to a predefined protocol: 4 caregivers will be required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube and the ventilator lines. The others will stand at each side of the bed. In the first step, the direction of the rotation will be decided giving priority to the side of the central venous lines. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. In the third step, the patient will be moved in the sagittal plane and maintained in that position for a short while to attach the cardiac electrodes to her/his back and to set a new bed sheet. In the last step, the patient will be turned to the complete prone position.

Locations

Country	Name	City	State
Italy	Federico Longhini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Pressure	Difference between the airway plateau pressure and the total positive end-expiratory pressure after an inspiratory and expiratory hold maneuvers, respectively	30 minutes after the prone positioning
Secondary	Respiratory system compliance	Driving pressure to the tidal volume ratio	30 minutes after the prone positioning
Secondary	Cardiac output	Liters of blood flow ejected from the heart per minute, measured through a pulmonary artery catheter	30 minutes after the prone positioning
Secondary	Pulmonary arterial pressure	pulmonary arterial pressure measured through a pulmonary artery catheter	30 minutes after the prone positioning
Secondary	End-Expiratory Lung Impedance	Measurement of the end expiratory lung volume, as assessed by the electrical impedance tomography	30 minutes after the prone positioning