ISRCTN87110165已完成未知
A prospective, single-arm, observational clinical follow-up study on the application of PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia: a European Registry (PHADER)
Phagenesis Limited (UK)0 个研究点目标入组 255 人开始时间: 2014年10月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 255
研究概览
简要总结
2020 results in https://doi.org/10.1016/j.eclinm.2020.100608 (added 09/12/2020)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Patients are eligible for study participation if they:
- •1. Are suspected to have oropharyngeal dysphagia with a Dysphagia Severity Ratings Scale (DSRS) score of 6 or higher
- •2. When eating independency would be jeopardised by partial or total paralysation of upper extremities and have a Functional Oral Intake Scale (FOIS) score equal to or lower than 5
- •3. When no oral food intake is possible and DSRS score is 12 and FOIS-score is 1 and have a Penetration-Aspiration Score (PAS) of 4 or higher
- •4. Have a well identified dysphagia causing neurological event such as, but not limited to, stroke or brain injury, potentially but not necessarily leading to the need of long-term mechanical ventilation or a tracheostomy
- •5. Are over 18 years old
- •6. Give themselves or have legal relatives/authorities representing themselves to give voluntary written informed consent
排除标准
- •1. Have an undefined date of medical event causing the dysphagia
- •2. Suffer from non-neurogenic dysphagia (e.g. cancer)
- •3. Participate in any other study potentially influencing the outcome of the Phagenyx treatment, both medicinal or medical device product related
- •4. Receive or have received within one month prior to the intended Phagenyx treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia
- •5. Have a cardiac pacemaker or a cardioverter defibrillator implanted unless the device can be switched off completely at the time of treatment delivery
- •6. Have experienced an oesophageal perforation, or have an oesophageal stricture or pouch;
- •7. Have an unstable cardiopulmonary status
- •8. Receive continuous oxygen treatment or have the equipment for such treatment permanently in place preventing the positioning of the Phagenyx Catheter (this does not exclude patients who are intubated or have a tracheostomy where 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 that can have the oxygen treatment temporarily stopped and equipment removed during Phagenyx treatment)
- •9. Are pregnant or nursing women
- •10. Require emergency treatment, preventing appropriate conduct of the subject informed consent process
- •11. Have a life expectancy less than the duration of the patient?s follow up period, i.e. less than three months
研究者
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