A Randomized, Sham Controlled, Double-blinded, Multi-center Trial to Evaluate the Efficacy of the VentFree Respiratory Muscle Stimulator to Assist Ventilator Weaning in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 49
- 主要终点
- Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
研究概览
简要总结
The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.
详细描述
Approximately 40% of patients who receive invasive ventilation require more than four days of ventilator support. Every additional day of mechanical ventilation results in increased patient morbidity and mortality and increased economic cost. Mechanically ventilated patients often develop expiratory muscle weakness, which has been linked to failed extubation and weaning.
Neuromuscular electrical stimulation (NMES) uses electrical pulses to induce a muscle contraction and has been shown to reduce or retard muscle atrophy. NMES applied to the abdominal wall muscles has been shown to improve respiratory function and assist ventilator weaning in spinal cord injury. Liberate Medical has previously shown that NMES applied to the abdominal wall muscles in synchrony with exhalation is feasible in patients receiving invasive mechanical ventilation. This study is a pivotal evaluation of the efficacy of exhalation synchronized abdominal NMES to assist ventilator weaning in critically ill patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥ 22 years of age.
- •Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.
排除标准
- •Participant has been receiving invasive mechanical ventilation for > 96 hours.
- •Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
- •Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization.
- •Participant has a BMI ≥ 40 Kg/m
- •Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
- •Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).
- •Participant has had open abdominal surgery ≤ 4 weeks prior to enrollment.
- •Participant has open or damaged skin at area of electrode placements.
- •Participant has a pacemaker and/or implanted electronic device.
- •Participant is known or expected to be pregnant. NOTE: A negative urine or blood pregnancy test will be documented during screening for women of child-bearing potential.
- •Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Participants receiving neuromuscular blockers may be enrolled after a ≥ 12-hour washout period.
- •Participant is tracheostomized at the time of enrollment.
- •Participant is on home non-invasive ventilation (except for CPAP or BiPAP for obstructive sleep apnea).
- •Participant is receiving or expected to receive comfort measures (palliative, hospice, comfort care, etc.) at the time of screening or enrollment.
- •Participant is participating in any of the following:
- •A study with the same or similar primary endpoint
- •A study investigating electrical stimulation or respiratory muscle therapy
- •Any study in which the investigator determines may interfere with the results of this study
- •Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- •Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
- •Participant or legally authorized representative is unwilling to provide written informed consent.
- •Participant or legally authorized representative is unable to provide written informed consent.
研究组 & 干预措施
VentFree Respiratory Muscle Stimulator
In the VentFree treatment group, abdominal functional electrical stimulation (FES) will be applied with a frequency of 30 hertz (Hz) and a pulse width of 350µs to cause a strong visible or palpable muscle contraction. The stimulation amplitude will be set to 90% of the participant's maximum tolerable level Discomfort associated with the maximum tolerable level will be recorded on the VAS with pain ratings from zero (no pain) to ten (worst pain). In uncommunicative patients, the maximum tolerable level will be determined as the stimulation intensity that results in a BPS >4 or CPOT >2. The stimulation amplitude will be titrated for each participant and each stimulation session. The stimulation amplitude will be evaluated every 10 (± 2) minutes after the start of each stimulation session and adjusted as necessary to maintain a consistent level of visual contraction and to ensure that the stimulation intensity remains within the participant's maximum tolerable level.
干预措施: Breath synchronized abdominal FES (Device)
Sham Respiratory Muscle Stimulator
In the sham group, abdominal functional electrical stimulation (FES) will be set to cause sensory stimulation but no muscle contraction. Abdominal FES will be applied with a frequency of 30 hertz (Hz), a pulse width of 350 µs and a stimulation amplitude that does not cause abdominal wall muscle contraction. The stimulation amplitude will initially be set at 10 mA and reduced in steps of 2 milliamp (mA) until no muscle contraction is seen.
干预措施: Sham breath synchronized abdominal FES (Device)
结局指标
主要结局
Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
时间窗: From first FES treatment to 28 days or ICU discharge, whichever occurs first
Successful liberation is defined as disconnection from mechanical ventilation that does not require invasive mechanical ventilation in the subsequent 7 days after disconnection, or until ICU discharge, or until live hospital discharge, whichever occurs first.
次要结局
- Cough peak flow(At 24 hours post-extubation)
- Time from first FES treatment administration to ICU discharge(From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first)
- Time from first FES treatment administration to hospital discharge(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Maximum expiratory pressure(At 24 hours post-extubation)
- Incidence of device-related adverse events(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of patients who were successfully liberated from mechanical ventilation(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of re-intubations(From date of first FES treatment administration to 90 days after treatment)
- Incidence of readmissions to the ICU(From date of first FES treatment administration to 90 days after treatment)
- Incidence of acute respiratory infections(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of readmissions to the hospital(From date of first FES treatment administration to 90 days after treatment)
- Mortality(From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of hospital acquired infections(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of tracheostomy(From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first)
- Maximum inspiratory pressure(At 24 hours post-extubation)
- Mobility as assessed by the ICU Mobility Scale(Date of ICU discharge or 90 days after treatment, whichever occurs first)
- Quality of life as assessed by EQ-5D (Quality of Life Survey)(At 90 days after treatment)