Effect of Adding Proprioceptive Neuromuscular Facilitation to Inspiratory Muscle Training on Weaning Off Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 93
- 主要终点
- • Time to Successful weaning
研究概览
简要总结
the goal of this clinical trial is to find out the effect of adding proprioceptive neuromuscular facilitation to inspiratory muscle training on weaning off mechanical ventilation. the main question it aims to answer is is there a significant difference in the effect of inspiratory muscle training combined with PNF on the duration of weaning in the mechanically ventilated ICU patients.
researchers will compare effect of (Inspiratory muscle training combined with PNF) to (Inspiratory muscle training) and control group.
participants will be mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, their ages older than 18 years. The selected patients will be mechanically ventilated due to respiratory failure and will randomly assigned into three equal groups.
详细描述
type of study: randomized control trial this study is a prospective interventional study one that will be conducted on ninety three mechanically ventilated patients with respiratory failure of both sexes their ages older than 18 years from intensive care unit and will randomly assigned into three equal groups:
- intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment.
- intervention group 2: include 31 mechanically ventilated patients will receive inspiratory muscle training combined with proprioceptive neuromuscular facilitation along with Conventional rehabilitation program plus medical treatment.
- Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.
Instrumentations:
A) Evaluation:
All the following will be measured for all patients who will participate in this study
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
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
- •Adults of both sexes
- •patients older than 18 years
- •Conscious and cooperative
- •Hemodynamic stability without significant vasopressor support.
- •No continuous sedation.
- •Mechanically ventilated due to type 1 or type 2 respiratory failure (RF) for at least 24 hours.
- •Mechanically ventilated in assisted ventilation mode
- •Are able to participate in training actively, weanable as regard shallow breathing index.
- •presence of weaning criteria as defined in the European Consensus Conference in 2007, including sedation reduction, spontaneous breathing cycles, Partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2) ≥ 150, absence of inotropes or vasopressors at high doses or increasing doses (< 1 mg/h), oxy-hemoglobin saturation (SaO2) > 90% with FiO2≤ 50%, positive end expiratory pressure (PEEP) ≤ 8 cmH2O, temperature between 36 and 39 °C.
排除标准
- •Hemodynamic or respiratory instability
- •Condition that can compromise weaning, such as heart failure.
- •Condition that can prevent adequate performance of inspiratory muscle training, such as neuropathy or myopathy.
- •Thoracic or abdominal surgery precluding the use of PNF exercises
- •Rib fractures
- •Current pregnancy
- •Cardiac arrest with a guarded neurological prognosis
- •Deep coma
研究组 & 干预措施
group (A) threshold inspiratory muscle training
threshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation.
干预措施: threshold inspiratory muscle training + conventional chest physiotherapy (Device)
group (B) PNF training + IMT
PNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute.
干预措施: proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy (Device)
group(C) Conventional Chest Physiotherapy only
Conventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation.
干预措施: Conventional Chest Physiotherapy (Other)
结局指标
主要结局
• Time to Successful weaning
时间窗: From enrollment to the end of treatment (an average of 7 to 14 days)
Successful weaning: defined as sustained spontaneous breathing \>48 hours post-extubation without need for reintubation or non-invasive ventilation.
• Maximum inspiratory pressure
时间窗: From enrollment to the end of treatment (an average of 7 to 14 days)
Maximum inspiratory pressure: to determine the inspiratory muscle strength before and after training. To measure the "negative inspiratory force" (NIF) through the ventilator settings menu (often available under "special procedures" or "lung mechanics")
• Diaphragmatic excursion
时间窗: From enrollment to the end of treatment (an average of 7 to 14 days)
Diaphragmatic movement is evaluated using (sonoscape sonar). The right hemidiaphragm is examined by two-dimensional (2D) and M-mode to record diaphragm excursion (displacement). The probe is placed immediately below the right costal margin in the midclavicular line in longitudinal scanning plane with the angle in cephalad direction to make the ultrasound beam perpendicular to the posterior third of the right hemidiaphragm and with the liver serving as an acoustic window.
次要结局
- • ICU length of stay(From enrollment to the end of treatment (an average of 7 to 14 days))
- Lung compliance(From enrollment to the end of treatment (an average of 7 to 14 days))
- Classification of patients according to the weaning process(From enrollment to the end of treatment (an average of 7 to 14 days))
研究者
Mohammed Shaaban Attya Abd-Alhafez
demonstrator
Beni-Suef University