Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

NCT ID: NCT05198986

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-02-28

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

ECMO Prone Position

After baseline assessment in supine position, patients will be positioned in prone position to assess modification of lung mechanics, aeration and hemodynamics

Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Federico Longhini

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna graecia University

Locations

Federico Longhini

Catanzaro, , Italy

Countries

Italy

Central Contacts

Federico Longhini, MD

Role: CONTACT

longhini.federico@gmail.com

+393475395967

Andrea Bruni, MD

Role: CONTACT

andreabruni87@gmail.com

+393401414553

Other Identifiers

ECMO-PP

Identifier Type: -

Identifier Source: org_study_id