Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

NCT05198986 | Unknown

• 1 other identifier: ECMO-PP
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Extra Corporeal Membrane Oxygenation; Prone Position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (1)

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

Other: Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)

Interventions

Prone Position during Extra Corporeal Membrane Oxygenation (ECMO) 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.

ECMO Prone Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will receive deep sedation and continuous infusion of neuromuscular blocking agents. Protective mechanical ventilation will be set in volume-controlled mode. A pulmonary artery catheter (PAC) will be also positioned and connected to a dedicated system for hemodynamic monitoring. After enrolment, a silicon 16-electrode belt of proper size will be positioned around the patient's chest between the 4th and 6th intercostal spaces and connected to the EIT device. The position of EIT belt will be therefore marked on the skin with a dermographic pencil to avoid its displacement. Invasive mechanical ventilation will be applied with a ventilator connected to the EIT device through a RS232 interface.

You may qualify if:

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

You may not qualify if:

• 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
• refusal of consent.

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Federico Longhini

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Federico Longhini, MD

  Magna graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Andrea Bruni, MD

CONTACT

+393401414553; andreabruni87@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 20, 2022
• Study Start: February 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after study completion and publication
• Access Criteria: On reasonable request

Locations

IT (1)