Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Negative Inspiratory Pressure (PNIP)
研究概览
简要总结
Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning failure,the investigators hypothesize that
- Specific inspiratory muscle training (SIMT) using threshold loaded breathing device (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle strength
- SIMT will improve lung function in patients with ventilatory dependence.
- SIMT will improve weaning success in patients with ventilatory dependence.
详细描述
Prolonged mechanical ventilation cause detrimental effects on lung function and high risk of lung complications and standard weaning protocols are not successful in a number of patients. The strength of the inspiratory muscles is important factors in the success of weaning. Although, the inspiratory muscles are trained by manipulating the ventilator sensitivity and made of ventilation in the traditional protocol, the muscle function might not improved sufficiently to sustain independent and spontaneous breathing. Consequently, specific inspiratory muscle training is indicated and has been studied in patient with weaning failure. However, there is little evidence available and no firm conclusion can be drown. Therefore, the purpose of this study is to determine whether specific IMT training using the local made loaded threshold IMT device can improve lung function and accelerate the weaning process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who have been mechanically ventilated > 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study.
- •Normal arterial blood gas (PaCO2 < 50mmHg, PaO2 > 60 mmHg on FiO2 <0.5 or SaO2 > 90%, PH 7.35-7.45).
- •Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors)
- •Good consciousness, cooperation and can sit in an upright position > 30 minutes
排除标准
- •Persistent homodynamic instability.
- •Severe breathlessness at rest when spontaneous breathing.
- •Coronary heart disease with angina.
- •Life threatening arrhythmia (VF, VT).
- •Sedation Ramsay scale > 2
- •Severity of disease APACHE II score > 29
研究组 & 干预措施
intervention group
Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University
干预措施: intervention group (Device)
结局指标
主要结局
Peak Negative Inspiratory Pressure (PNIP)
时间窗: every 7 day for 28 days
次要结局
- Vital capacity(every 7 day for 28 days)
- Tidal volume(every 7 day for 28 days.)
- Rate perceived breathlessness(every 7 day for 28 day)
- SpO2(every 7 day for 28 days.)
- Weaning success(every 7 day for 28 days.)
- Minute ventilation(every 7 day for 28 days.)
- End tidal carbondioxide (PetCO2)(every 7 day for 28 days.)
- Lung compliance(every 7 day for 28 days)
- Airway resistance(every 7 day for 28 days.)
- Heart rate(every 7 day for 28 days.)
- Respiratory rate(every 7 day for 28 days.)
研究者
Saikaew Chuachan
Associated Medical Science
Khon Kaen University