NL-OMON56776尚未招募3 期
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 - PREVENT
iberate Medical0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participant is >= 22 years of age.
- •2. Participant has been receiving invasive mechanical ventilation in an ICU for
- •<= 72 hours prior to enrollment.
- •3. Participant has been receiving invasive mechanical ventilation for >= 24
- •hours prior to enrollment.
- •4. Participant or legally authorized representative is willing and able to
- •provide written informed consent.
排除标准
- •1. Participant is scheduled or expected to be disconnected from mechanical
- •ventilation <= 24 hours after enrollment.
- •2. Participant has a BMI >=40.
- •3. Participant has no contraction of the abdominal wall muscles in response to
- •abdominal FES as determined by ultrasound.
- •4. Participant has a pre-existing neuromuscular or muscular disorder that could
- •affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré
- •5. Participant has had open abdominal surgery < 4 weeks prior to enrollment.
- •6. Participant has open or damaged skin at area of electrode placements.
- •7. Participant has a pacemaker and/or implanted electronic device (e.g.,
- •pacemaker or defibrillator).
- •8. Participant has expected or diagnosed epilepsy.
- •9. Participant is being treated for anaphylaxis.
- •10. Participant is known or expected to be pregnant.
- •NOTE: A negative blood or urine pregnancy test will be documented during
- •screening for women of child-bearing potential.
- •11. Participant is actively pharmacologically paralyzed at the time of
- •enrollment.
- •NOTE: Subjects receiving neuromuscular blockers may be enrolled after a >= 12
- •hour washout period.
- •12. Participant is ventilated as a result of an uncomplicated elective surgery.
- •13. The primary reason for ICU admission is an alcohol or drug overdose without
- •secondary complication.
- •14. Participant is tracheostomized at the time of enrollment.
- •15. Participant is on home non-invasive ventilation (except for CPAP for
- •obstructive sleep apnea).
- •16. Participant has a life expectancy < 6 months based on medical history.
- •17. 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
- •18. Participant is unable or unwilling to comply with protocol requirements,
- •including assessments, tests, and follow-up visits.
- •19. Participant has any other medical condition which in the opinion of the
- •Investigator will make participation medically unsafe or interfere with the
- •study results.
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