Evaluation of the Effectiveness of Transcutaneous Neuromuscular Electrical Stimulation as an Adjunct to Standard Treatment for Swallowing Disorders in Tracheotomized Patients Following Prolonged Mechanical Ventilation Weaning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 238
- 主要终点
- Prevalence of swallowing disorders after 21 days of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments, in patients following tracheotomy due to prolonged mechanical ventilation weaning
研究概览
简要总结
Dysphagia can reach a prevalence of up to 80% in intensive care patients. The implementation or prolonged presence of medical devices such as the intubation tube, tracheostomy, or nasogastric tube alters the physiology of swallowing and causes local injuries at several levels. Additionally, certain medical treatments impair swallowing physiology and the patient's alertness, further promoting the development of these disorders.
Management of dysphagia involves two main types of strategies: adaptive or compensatory maneuvers and rehabilitation techniques such as: performing praxis or swallowing exercises; physical stimulation (tactile or thermal); transcranial stimulation (electrical or magnetic); and finally, pharyngeal or transcutaneous electrical stimulation (NMES).
Patients hospitalized in intensive care often present with altered levels of alertness, asynchronous ventilation and swallowing, and reduced motor capabilities, making it difficult to perform techniques like praxis, food trials, or resistance swallowing exercises. NMES does not require active patient cooperation or the permanent presence of the therapist during the stimulation session, thus increasing the intensity of dysphagia rehabilitation and the early implementation of treatment in these patients, complementing conventional rehabilitation. Muscle and sensory stimulation through the application of NMES can help increase the strength of the muscles involved in swallowing and improve sensory capabilities. However, its effects have not yet been evaluated in tracheostomized patients undergoing weaning from prolonged mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Hospitalized in intensive care units, post-ICU rehabilitation, or weaning and rehabilitation services;
- •Presence of a tracheostomy for more than 72 hours due to difficult mechanical ventilation weaning;
- •Diagnosis of swallowing disorders (swallowing fiberoscopy);
- •Patient aged at least 18 years at the time of inclusion;
- •Affiliated to a social security scheme or beneficiary of such a scheme;
- •Written, free and informed consent of the patient or their next of kin.
排除标准
- •Contra- indication to cervical NMES;
- •History of swallowing disorders;
- •Patient with a spinal cord injury above C5 level;
- •History of head and neck cancer;
- •Person under legal protection measures;
- •Patient under guardianship or conservatorship;
- •Known pregnancy;
- •Limitation of care.
研究组 & 干预措施
Placebo Neuromuscular Electrical Stimulation (Placebo NMES)
Patients included in the control group will receive standard care and the control intervention. The Neuro Muscular Electrical Stimulation (NMES) will be applied through 2 pairs of electrodes to the anterior surface of the neck. The same frequency and pulse duration will be used. The intensity will be increased until a vibration/tingling sensation perceptible by the patient is produced. The device will then be turned off.
干预措施: Placebo Neuromuscular Electrical Stimulation (Placebo NMES) (Procedure)
Neuromuscular Electrical Stimulation (NMES)
The patient is comfortably positioned on their back, with the backrest at a 45° incline. Neuromuscular electrical stimulation (NMES) is applied through two pairs of electrodes placed on the front of the neck: one pair on the supra-hyoid muscles and the other on the infra-hyoid muscles. The electrodes are positioned using anatomical landmarks of the hyoid bone and the mandible. A current of 80 Hz with a pulse duration of 700 µs is applied to induce a muscle contraction. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, 5 days a week. The treatment is performed once per day.
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干预措施: Neuromuscular Electrical Stimulation (NMES) (Procedure)
结局指标
主要结局
Prevalence of swallowing disorders after 21 days of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments, in patients following tracheotomy due to prolonged mechanical ventilation weaning
时间窗: after 21 days of treatment
Evaluate the effectiveness of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments for swallowing disorders, on the prevalence of these disorders after 21 days of treatment, in patients who have undergone tracheotomy due to prolonged mechanical ventilation weaning.
次要结局
- Severity of swallowing disorders - the yale pharyngeal residue severity rating scale(21 days)
- Time to resume oral feeding at Day 21 after NMES initiation(At day 21 after initiation of NMES/placebo)
- Duration of mechanical ventilation(Day 21 after initiation of NMES treatment/placebo)
- Lenght of stay(From study inclusion (Day 0) until discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days))
- Time to tracheostomy decannulation(From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days))
- Prevalence of malnutrition(At day 21 after initiation NMES treament/place)
- Prevalence of malnutrition at unit discharge(At study end, defined as discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days))