Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dysphagia Severity Rating Scale (DSRS)
研究概览
简要总结
Neurogenic dysphagia occurs with disruption of neurological systems or processes involved in the execution of coordinated and safe swallowing. It is common in patients with neurological diseases, in particular in patients treated in Intensive Care Units (ICU) who are intubated (up to 62%) and / or tracheotomised (up to 83%). Dysphagia is one of the most common and most dangerous symptoms of many neurological diseases. In addition, neurogenic dysphagia can have a significant impact on quality of life, medication efficacy, and malnutrition.
Dysphagia is currently treated conservatively on evidence-based exercises, individually adapted to each patient. In the recent years pharyngeal electrostimulation has been established and shown a positive impact on outcome. In fact, this type of therapy has not only become an addition to the existing therapy, but an important alternative for patients difficult to treat by other means.
The Phagenyx® is a medical device, which has lately been used more frequently in multiple hospitals for treatment of neurogenic dysphagia. For nearly two decades pharyngeal electrostimulation has been further developed and optimised. This therapy initiates changes in the swallowing motor cortex through neuroplasticity as well as local changes in peripheral sensory architecture associated with swallowing. Bath and colleagues (2020) recently reported the efficacy of pharyngeal electrostimulation (Phagenyx®) in various neurological conditions.
As a result, of current published studies, the use of pharyngeal electrostimulation probe, in selected patients, with neurological diseases with moderate to severe neurogenic dysphagia will be evaluated.
This trial will initially start as quality assurance project with the aim to extent it into a monocentric based register study.
The Investigators aim to validate the effectiveness of pharyngeal electrostimulation for the treatment of moderate to severe neurogenic dysphagia by systematically recording specific dysphagia-relevant parameters. At present, it is still uncertain to what extent patients with neurogenic dysphagia in the context of a non-acute neurological disease could benefit from this method.
The research questions:
Does the use of the pharyngeal electrostimulation probe have an influence on the outcome of dysphagia in patients with moderate to severe neurogenic dysphagia? How long after therapy, can the use of the pharyngeal electrostimulation probe lead to oral food intake and/or removal of a tracheal cannula?
详细描述
Neurogenic dysphagia occurs with disruption of neurological systems or processes involved in the execution of coordinated and safe swallowing. It is common in patients with neurological diseases, in particular in patients treated in Intensive Care Units (ICU) who are intubated (up to 62%) and / or tracheotomised (up to 83%). Dysphagia is one of the most common and most dangerous symptoms of many neurological diseases. For example, dysphagia is found in 50% - 60% of all patients suffering a stroke or a traumatic brain injury. These patients are 4-times more likely to develop aspiration pneumonia and have a higher mortality rate. In patients with Parkinson's disease, pneumonia due to dysphagia is the most common cause of death. In addition, neurogenic dysphagia can have a significant impact on quality of life, medication efficacy, and malnutrition. Patients with neurogenic dysphagia, undergo standardized screening and, if indicated, a complementary dysphagia assessment as soon as possible to ensure the best possible care.
Dysphagia used to be treated conservatively with programmes of evidence-based exercises, individually adapted to each patient. In the recent years pharyngeal electrostimulation has been established and shown a positive impact on outcome. In fact, this type of therapy has not only become an addition to the existing therapy, but an important alternative for patients difficult to treat by other means.
The Phagenyx® is a medical device, which has lately been used more frequently in multiple hospitals for treatment of neurogenic dysphagia. For nearly two decades pharyngeal electrostimulation has been further developed and optimised. This therapy initiates changes in the swallowing motor cortex through neuroplasticity as well as local changes in peripheral sensory architecture associated with swallowing. Bath and colleagues recently reported the efficacy of pharyngeal electrostimulation (Phagenyx®) in various neurological conditions.
As a result of current published studies, the use of pharyngeal electrostimulation probe in selected patients with neurological diseases with moderate to severe neurogenic dysphagia will be evaluated.
This trial will initially start as quality assurance project with the aim to extent it into a multicentre based register study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurogenic dysphagia
- •Ischaemic and haemorrhagic strokes
- •Infra- as well as supra-tentorial
- •Polyradiculitis
- •Parkinson's disease
- •Multiple sclerosis
- •Traumatic brain injury
- •Post Covid-19 pat.
- •patients over the age of 18.
排除标准
- •Contraindication to nasogastric tube,
- •Unstable cardiac or respiratory condition that does not allow the insertion of the Nasogastric tube
- •Pacemakers
- •Implanted defibrillators (ICD)
- •Breastfeeding women
- •(Caution: interfering signals may be visible in ECGs, & EEGs with continuous recording).
结局指标
主要结局
Dysphagia Severity Rating Scale (DSRS)
时间窗: through study completion, an average of 1 year
The Dysphagia Severity Rating Scale (DSRS) describe the capacity of the patient to swallow food and fluids and if the patient needs help. The scale range from 0-12. 0= no dysphagia 12= severe dysphagia
Penetration Aspiration Scale (PAS)
时间窗: through study completion, an average of 1 year
Penetration Aspiration Scale (PAS) is measured during the Swallow endoscopy (FEES). The PAS is a measure of the penetration and aspiration of a bolus. In this study the investigators evaluate two semisolid and three liquid boluses. Scala ranges from 1-8. 1. Material does not enter the airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway 6. Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject
次要结局
未报告次要终点
研究者
Michaela Trapl-Grundschober
PhDr. Michaela Trapl-Grundschober, MSc, Departement of Clinical Neurology, Speech Therapist
Karl Landsteiner University of Health Sciences