Awake Prone Position for Early Hypoxemia in COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 26
- 主要终点
- Change in respiratory status
研究概览
简要总结
Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission.
The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
详细描述
The purpose of this multi-site trial is to investigate the use of prone positioning in SARS-CoV-2 infected patients who are not intubated. The APPEX-19 study is a pragmatic adaptive randomized controlled unblinded trial. The study compares a smartphone tool that recommends non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) to usual care.
Participants who are assigned to the intervention arm will receive a text message containing a link to an online website that reviews how to safely self-prone position and a recommendation to self-prone position 4 times for 1-2 hours each during the day and at night every 24 hours. Participants will also receive twice daily reminders to self-prone using the same smartphone platform.
All participants will receive twice daily Qualtrics online surveys to answer questions about which body positions they used in bed and their level of comfort and shortness of breath. Participants will receive these twice daily text messages until they are discharged, until they are transferred to the ICU, until they die, until their lung function declines, or until 14 days pass since enrollment. Thus, most participants will receive twice daily text messages for about 1 week; it is expected that almost all patients will receive twice daily text messages for no longer than 14 days. Medical charts will be reviewed daily to track routine clinical data to determine outcomes.
Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data coordinating center for this multisite trial. The unique design of the study means that if evidence accumulates that one treatment is better than the other, more participants will be chosen to receive the prone position intervention that works over time. Thus, the trial will both show what works, implement what works, and make sure that the most participants receive the treatment that works.
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
- 否
入选标准
- •Assigned to or admitted to a COVID-19 ward team at a participating site (these teams only admit patients who are under investigation for COVID-19 or who have confirmed COVID-19 infection) via the emergency department (ED) within the last 24 hours
- •Have access to their own functioning smartphone in the hospital room
- •English or Spanish-speaking
- •Ability to read simple instructions and answer simple written questions
排除标准
- •Baseline patient factors
- •Inability to operate the hospital bed
- •Inability to lie flat comfortably
- •Inability to lie flat without shortness of breath
- •Inability to turn over independently
- •Medical comorbidities
- •Hemoptysis in the last 2 days
- •Prior lung transplant
- •Acute issues
- •Deep venous thrombosis treated for less than 2 days
- •Unstable spine, femur, or pelvic fractures
- •Mean arterial pressure lower than 65 mmHg
- •Receiving ≥6 liters per minute of supplemental oxygen via nasal cannula, nasal pendant, or shovel mask
- •Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or non-rebreather mask)
- •Recent interventions
- •Chest tube in place
- •Tracheal surgery or sternotomy during the previous 15 days
- •Serious facial trauma or facial surgery during the previous 15 days
- •Cardiac pacemaker inserted in the last 2 days
- •Pregnancy
- •Comfort measures only status
结局指标
主要结局
Change in respiratory status
时间窗: up to 30 days
Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.
次要结局
- Length of time participant spends in the supine position(up to 30 days)
- Length of time participant spends standing or walking(up to 30 days)
- Hospital mortality(up to 30 days)
- Length of time participant spends in the prone position(up to 30 days)
- Length of time participant spends lying on side(up to 30 days)
- Length of time participant spends sitting up(up to 30 days)
- Invasive mechanical ventilation(up to 30 days)
- Dyspnea or difficult/labored breathing(up to 30 days)
- Loss of IV access as a consequence of turning in bed(up to 30 days)
- Acute respiratory distress syndrome (ARDS) diagnosis(up to 30 days)
- Discomfort with proning(up to 30 days)
- Length of hospital stay(up to 30 days)