The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Amount of aspirated secretion
研究概览
简要总结
The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years;
- •Admission to the ICU
- •Length of mechanical ventilation > 24 hours
- •Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg.
排除标准
- •Patients with primary neuromuscular disease.
- •Patients in exclusive paliative care.
- •Patients with contraindications to the use of mechanical insufflation- Exsufflation device.
结局指标
主要结局
Amount of aspirated secretion
时间窗: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy).
次要结局
- Static lung compliance(This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.)
- Airway resistance(This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.)
研究者
Augusto Savi
PhD
Hospital Moinhos de Vento