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Clinical Trials/NCT06184490
NCT06184490
Recruiting
Not Applicable

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

Hospital de Clinicas de Porto Alegre1 site in 1 country12 target enrollmentAugust 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prone Position
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
12
Locations
1
Primary Endpoint
Lung recruitment
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2023
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lung recruitment

Time Frame: 1 hour before prone - 2 hours before supine

Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography

Study Sites (1)

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