Impact of Negative Pressure Ventilation in Patients Hospitalized With Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Resolution of Hypercapnic Respiratory Failure
研究概览
简要总结
The study aims to find if using a Biphasic Cuirass Ventilation is as effective as using a Non invasive Positive Pressure Ventilation in patients admitted with acute hypercapnic respiratory failure.
详细描述
Patients presenting via Emergency Room or inpatients who are noted to be in acute hypercapnic respiratory failure will be approached for consent and if they are agreeable will be randomized to the standard of care arm which would be the use of Bilevel Positive pressure ventilation via face mask vs the intervention arm which would use the Biphasic Cuirass Ventilation.
Patients will be monitored and treated in the Medical ICU and will be regularly clinically assessed as per usual standard of care. The study investigators will obtain periodic Arterial/Venous Blood gas sampling to assess for improvement or lack thereof in patients Carbon dioxide levels.
If patients' condition doesn't improve or deteriorates their primary treating physician will have full authority to withdraw such patients from study and or change the modality of the patient's treatment.
This is a pilot study, and the investigators are aiming to compare the success rate of Biphasic cuirass ventilation when compared to non-invasive positive pressure ventilation.
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
can't be done as the two devices are completely different.
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission diagnosis of hypercapnic respiratory failure
- •pH between 7.20-7.35 in an ABG sample or pH between 7.16-.31 in a venous sample.
排除标准
- •Inmate/Prisoner
- •Contraindication for cuirass ventilator (open chest wound, flail chest, prior thoracic surgery)
- •Chest wall defect, neuromuscular disease or diaphragmatic paralysis.
研究组 & 干预措施
Conventional Arm
Patients will be placed on Non invasive positive pressure ventilation per current standard of care.
Intervention Arm
Patient in this arm will be placed on Biphasic Cuirass Ventilation
干预措施: Intervention Arm (Biphasic cuirass ventilation) (Device)
结局指标
主要结局
Resolution of Hypercapnic Respiratory Failure
时间窗: 1-3 days
Resolution of Hypercapnic Respiratory failure will be assessed and compared with the current standard of care which is non invasive positive pressure ventilation using Arterial or Venous Blood Gas analysis.
次要结局
未报告次要终点
研究者
Dennis Chairman
Assistant Professor of Clinical Medicine
University of Missouri-Columbia