VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Sensitivity
研究概览
简要总结
Background: Over one million patients in the US are estimated to undergo mechanical ventilation every year, and approximately 300,000 of them fail attempts at weaning. The morbidity and mortality of these patients is greater than in patients who are successfully weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation have the potential to benefit society both in terms of human suffering and cost.
Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation are in a catabolic state raises the possibility that strategies designed to produce an early recruitment, and improve the strength, of the expiratory muscles could improve weaning outcomes in difficult to wean patients.
The current investigation, which will be conducted in healthy subjects and in ambulatory patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1 and 2), and in patients who are difficult to wean from mechanical ventilation at RML Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study the physiological (respiratory) responses to such stimulation in assisting respiration in healthy subjects, in ambulatory patients with COPD and in patients requiring pronged mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity
时间窗: 10 minutes of resting breathing
Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.
Error rate
时间窗: 10 minutes of resting breathing
Number of false positive stimulation triggers over the total number of breaths taken.
次要结局
- Tidal volume(10 minutes of resting breathing)
- Respiratory rate(10 minutes of resting breathing)
- Minute ventilation(10 minutes of resting breathing)
- Esophageal pressure time product(10 minutes of resting breathing)
- Tension time index of the diaphragm(10 minutes of resting breathing)
- Ratio of tidal change in Pga to tidal change in Pes(10 minutes of resting breathing)
- Trans diaphragmatic pressure time product(10 minutes of resting breathing)
研究者
Franco Laghi, MD
Staff Physician
Edward Hines Jr. VA Hospital
