Prone Position With Different Types of Cushions in Patients With ARDS

Study Overview
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Brief Summary
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The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.

Detailed Description
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The prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) that promotes improved oxygenation with consequent reduction in mortality. Despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. The use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. The aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (EIT), gasometric data, and parameters of mechanical ventilation.

Official Title
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Prone Position With Different Types of Cushions in Patients With Acute Respiratory Distress Syndrome - Effects on Mechanics, Oxygenation, and Electrical Impedance Tomography Imaging

Conditions
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Prone Position, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Prone position with thoraco-abdominal cushion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18 years or more, with moderate or severe acute respiratory distress syndrome (ARDS), and indication of prone position Exclusion Criteria: Contra-indication to the prone position: intracranial pressure > 30 mmHg or cerebral perfusion pressure < 60 mmHg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmHg despite vasopressive therapy and pregnancy Severe acute respiratory distress syndrome (ARDS) caused b coronavirus disease 2019 (despite meeting the Berlin criteria for ARDS, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ARDS from other etiologies) contraindications for the use of Electrical Impedance Tomography (EIT) such as presence of a cardiac implantable electronic device Pulmonary transplantation Prone position before enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual prone position<br>Prone position with thoraco-abdominal support (cushions on the chest and hips, leaving the abdomen free) | |
| Experimental: Modified prone position<br>Prone position with lateral support (lateral cushions on the chest, hips and abdomen) | Procedure: Prone position with thoraco-abdominal cushion<br>* Prone position with cushions positioned laterally on the chest, abdomen, and pelvis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung recruitment | Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography | 1 hour before prone - 2 hours before supine |