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临床试验/NCT04853979
NCT04853979已完成不适用

Awake Prone Positioning in COVID-19 Suspects With Hypoxemic Respiratory Failure

Hamad Medical Corporation2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年5月16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
61
试验地点
2
主要终点
Proportion of patients requiring escalation to NIV (CPAP or BIPAP) or IV in each group

研究概览

简要总结

The investigator hypothesis is that early implementation of early, awake prone position for patients with COVID-19 pneumonia requiring oxygen therapy will reduce the need for escalation of respiratory support. Escalation of respiratory support is defined as the need for respiratory support with HFNO, NIV or IV.

详细描述

The world health organization has designated the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) as an ongoing pandemic and a public health emergency of international concern. The disease is estimated to be severe in 20% of patients and about 5-10% will need critical care with respiratory support. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.

Prone positioning causes a substantial improvement in oxygenation that appear to persist after the patient is returned to a supine position. It has also been shown to have a significant mortality benefit in invasively ventilated ARDS patients. Observational studies have shown improvement in oxygenation with awake prone positioning in non-intubated patients with COVID-19 pneumonia. There is no published RCTs to date. It remains unclear whether prone positioning averts invasive or non-invasive ventilation, accelerates recovery, or reduces mortality. Similarly, there is no data on presumed viral pneumonia. Future studies are needed to identify the optimal indications for, duration of pronation, and assessment of response.

Hypothesis: The investigator hypothesis is that early implementation of early, awake pronation for patients with Covid19 pneumonia requiring oxygen therapy will reduce the need for escalation of respiratory support. Escalation of respiratory support is defined as the need for respiratory support with HFNO, NIV or IV Research participants: Adults 18 years and older with suspected or confirmed COVID-19 presenting to HMC with hypoxemic respiratory failure (PF<200 or SpO2 less than 94% on FiO2>=0.4 or =>5 lit/min O2)

Design: This is a non-blinded randomized controlled trial. Participants will be randomized to one of two study arms:

  1. Intervention arm: Any combination of prone or side position (defined as any part of the anterior chest wall being in contact with the bed) for at least 3 hours and up to 16 hours per day during wakefulness. Patients will be asked to prone on three occasions: morning, afternoon and evening. Breaks of 30-120 min are allowed in sitting position or supine each 4 hours. Bed elevation of >30 degrees will be maintained unless otherwise requested by the patient. No control or intervention is made during sleep periods. Intervention will last for up to 3 days or until the patient achieves oxygen saturations of 94-98% on room air. Oxygen delivery may be via NC, HM, HFNC or NIV.
  2. Control arm: Usual care (no Prone unless asleep and assumes this position spontaneously). The patient is able to adopt their preferred natural position. The bed will be elevated >30 degrees unless requested otherwise by the patient. However prone position may be used as rescue therapy if oxygen requirements are =>15 lit/min O2 or HFNC/NIV with FiO2 =>0.6 with O2 saturation less than 90% at the discretion of the treating physician.

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

盲法说明

Prone position cannot be masked to any member in the trial

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

  • All adults with suspected or confirmed COVID-19 and hypoxemia respiratory failure.
  • SPO2 less than 94% or Oxygen requirment of more than 5 liters.
  • Requiring oxygen therapy in Hospital< 24 hours

排除标准

  • Clinical assessment for immediate intervention.
  • RR>60bpm
  • Hemodynamics instability with need for vasopressors.
  • Pregnancy
  • Impaired LOC, agitation or lack of cooperative patient.
  • Unstable spine or pelvis
  • Abdominal wound
  • Pnemothorax
  • Any injury or illness that may be worsened or result in pain as a result of prone position.
  • Any contraindicaton to prone position.

结局指标

主要结局

Proportion of patients requiring escalation to NIV (CPAP or BIPAP) or IV in each group

时间窗: 30 days

To assess the potential for prone position to reduce the requirement for escalation of respiratory support.

次要结局

未报告次要终点

研究者

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

Tim Richard Edmund Harris

Vice chairman Education Emergency Department

Hamad Medical Corporation

研究点 (2)

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