Functional Inspiratory Versus Expiratory Muscle Electrical Stimulation on Weaning Outcomes in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- pH (arterial blood gas)
研究概览
简要总结
The Goal of This Clinical Trail is
- To find out the difference in the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on weaning outcomes mechanically ventilated patients.
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Laboratory investigation (Arterial Blood Gases).
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Sonar parameters (Diaphragmatic excursion, Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration and abdominal muscles wall thickness). To evaluate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on (ICU length of stay and Spontaneous Breathing Trail (SBT)).
详细描述
Type of Study: This study will be randomized clinical trial. Study Procedures: 100 mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, Beni-Suef University Hospital, their ages range from 45 to 65 years.
The selected patients will be all mechanically ventilated due to respiratory failure and randomly Participants will be randomly assigned to the three study groups and one control group . We will prepare (100) identical envelops, (25) of them will be filled with a label identifying Group (A) with all instruction details, while the second (25) will be filled with a label identifying the Group (B), the third (25) will be filled with a label identifying the Group (C), the last (25) will be filled with a label identifying the Group (D). All envelops will be prepared by the investigator and sealed before starting enrollment:
- Study group (A) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (B) include mechanically ventilated patients will receive Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (C) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Control group (D) include mechanically ventilated patients will receive early rehabilitation program plus medical treatment.
A) Measurement procedures:
- ICU length of stay: The number of days from ICU admission to ICU discharges
- Monitoring :
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All mechanically ventilated patients will be:
- •Their ages range from 45 to 65 years.
- •Their BMI is from 25-29.9kg/m
- •Mechanically ventilated for at least 24 hours.
- •They all have hypoxemic respiratory failure
- •Glasgow coma score (GCS) ranged from 6 to
- •Richmond Agitation-Sedation Scale score: -2 to +2
- •Patients and their relatives had written informed consent.
排除标准
- •Hemodynamically unstable patients.
- •Patients with rib fractures.
- •Patients with implanted pacemaker.
- •Obese (BMI greater than 30 kgm2).
- •Tachycardia.
- •Uncontrolled hypertension.
- •History of neuromuscular disease at admission.
- •Spinal injuries.
- •Inability to trigger mechanical ventilation
- •Pregnancy
- •An anticipated stay on the ventilator <72 h at the time of study
- •Patients who cannot attach electrodes due to local skin damage or infection
- •Patients with Severe intestinal gas accumulation, structural abnormalities, and other reasons that prevent ultrasound detection of diaphragm movement.
- •Congenital myopathies or neuropathies, and contraindications for expiratory muscle FES (cardiac pacemaker, refractory epilepsy, recent (< 4 weeks) abdominal surgery).
- •Patients with unrelieved pneumothorax and restricted diaphragm movement disorders.
- •Chest or diaphragm malformation
研究组 & 干预措施
Group A
Inspiratory muscle FES by Flexistem Digital electrical muscle stimulator +Early rehabilitation program. The current is pulsed, biphasic, and symmetric, with Frequency of 30 hertz , Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. Two electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body
干预措施: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator (Device)
Group A
Inspiratory muscle FES by Flexistem Digital electrical muscle stimulator +Early rehabilitation program. The current is pulsed, biphasic, and symmetric, with Frequency of 30 hertz , Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. Two electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body
干预措施: Early rehabilitation program (Device)
Group B
Expiratory muscle FES by Flexistem Digital electrical muscle stimulator+Early rehabilitation program. FES is applied for 30 min, two sessions daily, until patients are weaned from mechanical ventilation, but no longer than six weeks. Stimulation will be applied during exhalation and via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. settings are as follows: Frequency 30 Hz, pulse width 352 µs and a current intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA . Then we amend the protocol to allow a maximum intensity of 100 mA . Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased.
干预措施: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator (Device)
Group B
Expiratory muscle FES by Flexistem Digital electrical muscle stimulator+Early rehabilitation program. FES is applied for 30 min, two sessions daily, until patients are weaned from mechanical ventilation, but no longer than six weeks. Stimulation will be applied during exhalation and via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. settings are as follows: Frequency 30 Hz, pulse width 352 µs and a current intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA . Then we amend the protocol to allow a maximum intensity of 100 mA . Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased.
干预措施: Early rehabilitation program (Device)
Group C
Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
干预措施: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator (Device)
Group C
Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
干预措施: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator (Device)
Group C
Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
干预措施: Early rehabilitation program (Device)
Group D (Control Group)
early rehabilitation program plus medical treatment
Rehabilitation therapy which consisted of six levels:
Level 0 turning over once every 2 h for unconscious patients with unstable vital signs level 1-2 in addition to turning over, maintaining joint range of motion to prevent muscle atrophy, and placing normal limb position for conscious patients who could sit up for at least 20 min, 2 times a day Level 3 similar to level 2, but sitting on the edge of the bed for patients who could perform upper-limb anti-gravity training Level 4 similar to level 3, but standing up or sitting in a chair for at least 20 min a day for patients who could perform lower-limb anti-gravity training Level 5 patients actively moved from the bed and walked bedside
干预措施: Early rehabilitation program (Device)
结局指标
主要结局
pH (arterial blood gas)
时间窗: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaO₂ (mmHg, arterial blood gas)
时间窗: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaCO₂ (mmHg, arterial blood gas)
时间窗: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
SaO₂ (%)
时间窗: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
HCO₃ (mmol/L, arterial blood gas)
时间窗: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
次要结局
- Diaphragmatic Excursion(Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation)
- Diaphragmatic Fractional Thickness(Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation)
- Abdominal Muscles Wall Thickness(Baseline at the start of the study and after Successful weaning from mechanical ventilation)
研究者
Ayah Japer Muhammad Muhammad Abu-Bakr
physiotherapist
Beni-Suef University