ISRCTN18137204已完成不适用
Benefit of PHAryngeal electrical STimulation for early de-cannulation in TRACheotomised stroke patients with neurogenic dysphagia : a prospective randomized single-blinded interventional study (PHAST TRAC study)
Phagenesis Limited0 个研究点目标入组 80 人开始时间: 2015年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27807279 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30170898
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Haemorrhagic or ischaemic stroke
- •2. Supratentorial
- •3. Mechanically ventilated for a minimum of 48 hours after the stroke event
- •4. Tracheotomised for any reason
- •5. Weaned from mechanical ventilation
- •6. Not taking sedatives for a minimum of 3 days
- •7. Ineligible for decannulation for a minimum of 10 days after the stroke event
- •8. Ineligible for decannulation for a minimum of 24 hours and a maximum of 72 hours after the first decannulation assessment
- •9. Cannot receive oral food (DSRS=12 and FOIS = 1)
- •10. Richmond Agitation and Sedation Scale > – 1
- •11. > 18 years old
- •12. Voluntary written informed consent provided by patients or their legal relatives/authorities
排除标准
- •Current exclusion criteria as of 27/07/2015:
- •1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed)
- •2. Pre-existing dysphagia
- •3. Infratentorial stroke
- •4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder)
- •5. Non-neurogenic dysphagia (e.g., cancer)
- •6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease)
- •7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form
- •8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia
- •9. Have a pacemaker or an implantable defibrillator
- •10. Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe
- •11. Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe
- •12. Receive oxygen therapy whilst the oxygen supply is in place or in operation
- •13. Pregnant or nursing women
- •14. Requiring emergency treatment that prevents the appropriate informed consent process
- •15. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months)
- •Previous exclusion criteria:
- •1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed)
- •2. Pre-existing dysphagia
- •3. Infratentorial stroke
- •4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder)
- •5. Non-neurogenic dysphagia (e.g., cancer)
- •6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease)
- •7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form
- •8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia
- •9. Cardiac pacemaker or cardioverter defibrillator, unless device can be switched off completely at the time of treatment
- •10. Oesophageal perforation, oesophageal stricture or pouch
- •11. Unstable cardiopulmonary status
- •12. Severe pneumonia that cannot be stabilised by medication and prevents decannulation
- •13. Receiving continuous oxygen treatment or having equipment for such treatment permanently in place, preventing the positioning of the Phagenyx catheter (does not exclude patients who are intubated or have a tracheotomy in which an inflated balloon creates a firm barrier between the space where oxygen might be present (trachea/lungs) and the space where the electrical stimuli are delivered (oropharynx), or patients who can have the oxygen treatment temporarily stopped and equipment removed during PES treatment)
- •14. Pregnant or nursing women
- •15. Requiring emergency treatment that prevents the appropriate informed consent process
- •16. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months)
研究者
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