Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Incidence of intubation
研究概览
简要总结
A pilot study to investigate the effects of the prone positioning (PP) on hospital patients diagnosed with COVID-19 pneumonia.
Investigators that early self-proning may prevent intubation and improve mortality in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).
Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will be enrolled to the study.
All participants will be screened and those that meet inclusion and exclusion criteria will be enrolled to one of two groups: one with prone positioning (on the belly) and the other with standard supine positioning (on the back). The patient and nursing staff will monitor times spent in various positions.
Outcome measures include incidence of intubation, max oxygen requirements, length of hospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.
详细描述
In hypoxic respiratory failure, placing patients in the prone position improves ventilation to perfusion matching, alveolar recruitment, and alveolar to arterial oxygen gradients. Specifically, in Acute Respiratory Distress Syndrome ARDS, proning intubated patients improves overall mortality. With the emergence of SARS-COV-2, hospitals around the world have seen a marked increase in patients with acute hypoxic respiratory failure and ARDS. This surge in cases has prompted a search for more effective strategies to reduce intubation and improve patient morbidity and mortality. One such strategy is that of voluntary proning, in which awake patients are instructed to prone themselves (Early PP With High Flow Nasal Cannula (HFNC) Versus HFNC in COVID-19 Induced Moderate to Severe ARDS) (COVID-19 smArtphone-based Trial of Non-ICU Admission Prone Positioning (CATNAP)).
This trial proposes a voluntary proning strategy in patients admitted to the hospital, not yet requiring mechanical ventilation. Given the clear evidence that proning improves outcomes in ARDS, investigators hypothesize that early, voluntary self-proning may prevent intubation and improve mortality in patients with SARS-COV-2.
Methods
This is a pilot study of up to 100 participants at UCHealth facilities.
Patients will be assessed if they can self prone safely and be assessed against inclusion and exclusion criteria within 12 hours of admission and randomized to either prone or supine positioning. Baseline labs will be measured and all participants will be monitored continuously via pulse oximetry.
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
- 否
入选标准
- •Patients admitted to the hospital floor with primary diagnosis of confirmed COVID-19 pneumonia and respiratory failure requiring greater than or equal to 2 Liters(L) Nasal Cannula (NC) to maintain SpO2>90%
- •Ability to independently change positions in bed
- •Able to tolerate prone positioning
- •Age greater than 18
排除标准
- •ICU admission on arrival
- •Respiratory distress requiring immediate intubation
- •Respiratory Rate(RR)>35/min, accessory respiratory muscle use (ex. speaking in short sentences), signs of respiratory muscle fatigue, altered mental status, or inability to protect airway
- •Chest or facial trauma, pneumothorax or other contraindication to prone positioning (i.e., spinal instability, recent abdominal surgery, pregnancy, etc)
- •Hemodynamically unstable
- •Heart Rate (HR)>120 bpm, Systolic Blood Pressure (SBP)<90 mmHg, Mean Arterial Pressure (MAP)<65 mmHg or requirement for vasopressor
- •Nausea and vomiting
- •Pregnancy
- •Refusal or inability to tolerate initial prone positioning due to comfort
结局指标
主要结局
Incidence of intubation
时间窗: Through study completion, an average of 6 days
Incidence of intubation
次要结局
- Mortality(Through study completion, an average of 6 days)
- Ventilator-free days(Through study completion, an average of 6 days)
- Treatment failure of prone positioning due to worsening SpO2 status while prone(Through study completion, an average of 6 days)
- Maximum oxygen requirement(Through study completion, an average of 6 days)
- Length of Stay(Through study completion, an average of 6 days)
研究者
Lucie Uncapher
Investigator
Poudre Valley Health System