ISRCTN98886991进行中（未招募）4 期
Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST)
niversity of Nottingham0 个研究点目标入组 800 人开始时间: 2021年10月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/11/2023:
- •1. Hospitalised adults (age =18 years)
- •2. Recent (4-31 days) ischaemic or haemorrhagic anterior or posterior circulation stroke (as diagnosed clinico-radiologically) at a comprehensive or primary care stroke centre
- •3. Clinical dysphagia defined as a functional oral intake scale score of 1 (nothing by mouth, feeding by nasogastric tube [NGT]/percutaneous endoscopic gastrostomy [PEG] tube), 2 (tube dependent with minimal attempts of food or liquids) or 3 (tube dependent with consistent oral intake of food or liquids)
- •4. NIHSS item 1a score of 0, 1 or 2 (where the patient requires repeated stimulation to arouse)
- •Previous inclusion criteria:
- •1. Hospitalised adults (age =18 years)
- •2. Recent (4-31 days) ischaemic or haemorrhagic anterior or posterior circulation stroke (as diagnosed clinico-radiologically) at a comprehensive or primary care stroke centre
- •3. Clinical dysphagia defined as a functional oral intake scale score of 1 (nothing by mouth, feeding by nasogastric tube [NGT]/percutaneous endoscopic gastrostomy [PEG] tube) or 2 (tube dependent with minimal attempts of food or liquids)
排除标准
- •Current exclusion criteria as of 14/11/2023:
- •1. Non-stroke dysphagia, e.g. due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer
- •2. Pre-stroke dysphagia or dependency (modified Rankin scale, mRS 4/5)
- •3. NIHSS item 1a score of 2 (where the patient only responds to pain) or NIHSS item 1a score of 3
- •4. Ongoing or anticipated ventilation/intubation/tracheostomy
- •5. Ongoing treatment of dysphagia with other forms of electrical / magnetic stimulation e.g. NMES, TCDS, rTMS
- •6. Malignant middle cerebral artery syndrome (although this typically presents before 4 days)
- •7. Pacemaker, cochlear implant or implantable cardioverter-defibrillator
- •8. Need for >35% of oxygen
- •9. Patient expected to be repatriated to a separate organisation
- •10. Patient expected to be rehabilitated at a separate organisation
- •11. Patient not likely to be in the treating hospital for at least 14 days
- •12. Two or more NGT tubes pulled out unless nasal bridle in place
- •13. Investigator feels patient will not tolerate PES catheter
- •14. Expected to be discharged or transferred to a site not running the trial during the PES treatment period
- •15. Pregnancy if known at time of enrolment
- •16. Participating in another randomised controlled treatment trial for post-stroke dysphagia
- •17. Palliative care
- •Previous exclusion criteria:
- •1. Non-stroke dysphagia, e.g., due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer
- •2. Pre-stroke dysphagia or dependency (modified Rankin scale [mRS] 4/5)
- •3. Ongoing or anticipated ventilation/intubation/tracheostomy or use of electrical or magnetic stimulation
- •4. Malignant middle cerebral artery syndrome
- •5. Pregnant
- •6. Pacemaker
- •7. Need for >2 litres of oxygen
- •8. Two or more NGT pulled out unless nasal bridle in place
- •9. Investigator feels the patient will not tolerate PES catheter
研究者
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