NCT07529210

Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Hopital Forcilles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dysphagia
• NeuroMuscular Electrical Stimulation

Interventions

Type	Name	Description
PROCEDURE	Neuromuscular Electrical Stimulation (NMES)	The patient will be comfortably positioned on their back, with the backrest inclined at 45°. NMES will be applied via two pairs of electrodes on the anterior neck. One pair of electrodes will be placed on the suprahyoid muscles and the other on the infrahyoid muscles. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day. Each department is encouraged to identify a time slot to facilitate the organization of care and avoid non-completion of the treatment. The duration of the session and the frequency of the intervention's application were chosen based on data from a recent systematic review of randomized controlled trials comparing the effectiveness of NMES versus conventional treatment. The included studies mostly had session durations around 30 minutes, 2 to 5 times per week, for a period of 2 to 6 weeks.
PROCEDURE	Placebo Neuromuscular Electrical Stimulation (Placebo NMES)	NMES will be applied via two pairs of electrodes on the anterior neck. Two electrodes will be placed above the hyoid bone, on either side, between the hyoid bone and the mandible. The other two electrodes will be placed on either side of the thyroid cartilage. The patient will also be comfortably positioned in a supine position, with the backrest inclined at 45°. The same frequency and pulse duration will be used. The intensity will be increased until the patient perceives a vibrating/tingling sensation. The device will then be turned off. The control intervention begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day at a time slot chosen by each center.

Timeline

• Start date: 2026-03-26
• Primary completion: 2028-06-01
• Completion: 2028-06-30
• First posted: 2026-04-14
• Last updated: 2026-04-14