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临床试验/NCT05130541
NCT05130541已完成不适用

Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study

New York Hospital Queens2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
2
主要终点
All-cause mortality

研究概览

简要总结

The aim of this proposal is to study whether proning, a technique that has previously been shown to improve lung function in patients with acute respiratory distress syndrome (ARDS), can prevent those with mild to moderate symptoms of COVID-19 from progressing to severe disease when initiated early, thereby averting intubation, reducing hospitalization, and, ultimately, decreasing mortality.

详细描述

COVID-19 is a global pandemic caused by the novel coronavirus SARS-COV-2. At this time, SARS-CoV-2 is believed to infect alveolar cells, directly impairing lung function and eliciting a profound inflammatory response that further damages the lungs. Between 1 in 20 and 1 in 10 patients infected with this virus die.

A crucial decision point in the treatment of patients with COVID-19 in the Emergency Department is the decision to admit to the hospital for further treatment, or discharge the moderately symptomatic (hypoxic and feel ill) but not critically ill patients. However, patients who present with initially mild to moderate symptoms may progress to severe disease. There is, therefore, an unmet need to identify interventions that prevent progression to critical illness in moderately symptomatic patients.

Anecdotal reports from Emergency Physicians suggest that alternating prone and supine positioning (i.e. instructing the patient to periodically turn over) improves hypoxia and delays intubation. Dubbed proning, this technique improves hypoxia in 6-7 out of 10 intubated patients with severe acute respiratory distress syndrome (ARDS). Alternating supine and prone positioning improves the recruitment of alveoli, improves ventilation-perfusion matching, increases end-expiratory lung volumes, and improves pulmonary lymphatic drainage.

This proposal is innovative because it studies the extension of an intervention previously restricted to patients in the intensive care units with severe acute respiratory distress syndrome (ARDS). Current literature on proning in awake patients with ARDS is limited to retrospective studies with no randomized controlled trials. Further, no clinical trials to date have explored the benefits of early awake proning in COVID-19.

The development of a treatment that prevents disease progression and hospitalization in patients moderately ill with COVID-19 would decrease morbidity and mortality from COVID-19 as well as decrease the utilization of scarce healthcare resources. In addition, this trial would be the first randomized controlled-trial, contributing significantly to the nascent evidence base on treatment for COVID-19.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting to the ED with symptoms suggestive of COVID-19
  • Assessed by ED attending physician to not require emergent intubation
  • Normal mental status and ability to communicate symptoms/distress
  • Able to follow instructions independently

排除标准

  • Severe respiratory distress requiring immediate intervention
  • Unable to follow verbal instructions
  • Unable to communicate their needs, symptoms, or distress
  • Inability to tolerate prone positioning due to mental status or habitus

结局指标

主要结局

All-cause mortality

时间窗: Within 30 days of discharge from hospital

All-cause mortality

Need for intubation

时间窗: At any time during first hospitalization for hypoxia from COVID-19 up to 2 months

Need for intubation

次要结局

  • Number of repeat visits for same complaint(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Chary

Instructor

New York Hospital Queens

研究点 (2)

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