NCT04694638已完成不适用
The Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in Acute Hypoxemic and/or Hypercapnic Respiratory Failure Secondary to COVID-19 Infection: A Feasibility, Safety Phase One, Open Label Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Rate of intubation
研究概览
简要总结
This research aims to understand if prone positioning combined with high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed COVID19 infection or suspected COVID19 infection.
- •Patients requiring HFNC or NIPPV
- •Patients who are clinically stable and able to tolerate the changes in position that are routinely conducted as part of the standard of care in the medical ICU.
- •Patient should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
- •Able to actively participate in Assisted Manual Pronation Therapy per nursing assessment.
排除标准
- •Contraindication for prone positioning:
- •Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
- •Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
- •Tracheal surgery or sternotomy during the previous 15 days
- •Serious facial trauma or facial surgery during the previous 15 days
- •Deep venous thrombosis treated for less than 2 days
- •Cardiac pacemaker inserted in the last 2 days
- •Unstable spine, femur, or pelvic fractures
- •Hemodynamic instability or severe cardiac arrhythmia (chronic AFib is not a contraindication). Mean arterial pressure lower than 60 mm Hg, >1 vasopressor agent or Norepinephrine equivalent dose >0.06 mcg/kg/min
- •Pregnant women
- •Single anterior chest tube with air leaks
- •Burns on more than 20 % of the body surface
- •Delirium or altered mental status increasing fall risk while in prone position.
- •End-of-life decision before inclusion
- •Subject deprived of freedom, minor, subject under a legal protective measure
- •Unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment
- •Lacking capacity to provide informed consent.
- •Individuals with mechanical or vascular disease precluding safe displacement of the head, for example: cervical spinal fusion, limited range of motion, or severe vascular occlusive disease of the head and neck.
- •Body mass index (BMI) greater than 70 kg/m2, or unable to actively participate in Assisted Manual Pronation Therapy per nursing assessment at any BMI value.
结局指标
主要结局
Rate of intubation
时间窗: 1 year
Number of critically ill patients with acute hypoxemic and/or hypercapnic respiratory failure, secondary to COVID-19 infection to require intubation and mechanical ventilation
次要结局
- Incidence of hypotension and cardiac arrhythmias and other nursing-related risks of combining prone positioning with high-flow nasal cannula and non-invasive positive pressure ventilation(1 year)
研究者
Gustavo A. Cortes Puentes
Principal Investigator
Mayo Clinic
研究点 (2)
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