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临床试验/NCT04612608
NCT04612608已完成不适用

Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery

Peter Morris2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
2
主要终点
highest value per day of mechanical ventilation of total respiratory system compliance

研究概览

简要总结

The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.

详细描述

The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be randomized into two treatment groups. One treatment arm will deliver scheduled sessions of upright bed positioning (study intervention), while the other treatment arm receives routine bed position care (care provided exclusively with the bed in the supine position). ICU Practitioners know that positional changes improve clinical outcomes when turning patients from supine to prone (back to belly); however, other positional changes including upright positioning are far less studied. It is well known that in ARDS patients who become proned, an improvement in aeration occurs in the dorsal lung regions (prone positioning has been shown to reduce ARDS mortality). Thus the investigators predict that in this study, the upright positioning holds the potential to further recruit collapsed lung areas. Augmentation of aerated lung while in the upright position is expected to increase the highest value measured per ventilator day of the respiratory system compliance in the upright bed position arm, in a greater fashion than the highest value measured per ventilator day of daily total respiratory system compliance for the usual care arm.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Berlin criteria ARDS

排除标准

  • ARDS greater than 72 hours
  • Neurologic disease known to prolong weaning
  • Pregnancy
  • Known diagnosis of pulmonary fibrosis
  • Implanted cardiac pacer/defibrillator

结局指标

主要结局

highest value per day of mechanical ventilation of total respiratory system compliance

时间窗: from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28

total respiratory system compliance measured 4x daily for each day of mechanical ventilation

次要结局

未报告次要终点

研究者

发起方
Peter Morris
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Morris

Professor

University of Kentucky

研究点 (2)

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