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临床试验/NCT06184490
NCT06184490招募中不适用

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 Alegre2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
2
主要终点
Lung recruitment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years or more, with
  • moderate or severe acute respiratory distress syndrome (ARDS), and
  • indication of prone position

排除标准

  • 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

结局指标

主要结局

Lung recruitment

时间窗: 1 hour before prone - 2 hours before supine

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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