Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure
• Intervention / Treatment: Other: Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Federico Longhini, MD; Phone Number: +393475395967; Email: longhini.federico@gmail.com
• Study Contact Backup: Name: Andrea Bruni, MD; Phone Number: +393401414553; Email: andreabruni87@gmail.com

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Federico Longhini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Prone Position; Extra Corporeal Membrane Oxygenation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ECMO-PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deindividualized data will be share on reasonable request to the Principal Investigator after study completion and publication
• IPD Sharing Time Frame: Data will be available after study completion and publication
• IPD Sharing Access Criteria: On reasonable request
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No