Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Therapeutic failure
研究概览
简要总结
The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.
详细描述
The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90%
- •Treating physician indicated prone position as instructed by the institutional protocol
- •Patient capable of changing position with minimal help from the personnel
排除标准
- •Patient requiring immediate intubation
- •Patient requiring non-invasive mechanical ventilation
- •Respiratory Rate > 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway
- •PaCO2 > 50mmHg
- •Hemodynamic instability (defined by Heart Rate > 120, Systolic Pressure < 90mmHg, Mean Arterial Pressure < 60mmHg or requiring vasopressor support)
- •Obesity with BMI > 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2)
- •Persistent vomiting
- •Facial or thoracic trauma or recent surgery contraindicating the prone position
- •Pregnancy > 20 weeks
结局指标
主要结局
Therapeutic failure
时间窗: At 14 days
Defined by death or intubation or use of non-invasive ventilation
Mortality
时间窗: At day 28
Number of patients that die
Length of hospital stay
时间窗: At 28 days
Number of days spent by the patients at the hospital
Days requiring high flow nasal oxygen
时间窗: At 28 days
Number of days the patients require high flow nasal oxygen therapy
Days requiring supplemental oxygen
时间窗: At 28 days
Number of days the patients require supplementary oxygen
Displacement of invasive devices during position changes
时间窗: At 28 days
Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes
Occurrence of pressure ulcers on the anterior surface of the body
时间窗: At 28 days
Number of patients that develope pressure ulcers on the anterior surface of the body
次要结局
- Delirium(At 28 days)
- Respiratory superinfection(At 28 days)
- Caloric intake(At 28 days)
- Proteic intake(At 28 days)