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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia; NeuroMuscular Electrical Stimulation
• Intervention / Treatment: Procedure: Placebo Neuromuscular Electrical Stimulation (Placebo NMES); Procedure: Neuromuscular Electrical Stimulation (NMES)

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aymeric PhD LE NEINDRE; Phone Number: +33160646093; Email: aleneindre@cognacq-jay.fr
• Study Contact Backup: Name: Andreia GOMES LOPES; Phone Number: +33160646293; Email: alopes@cognacq-jay.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.
Experimental: 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. Let me know if you need further adjustments or explanations!	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	after 21 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of swallowing disorders - the yale pharyngeal residue severity rating scale	Comparatively evaluate the effectiveness of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments for swallowing disorders in patients who have undergone tracheotomy due to prolonged mechanical ventilation weaning on the severity of swallowing disorders at 21 days of NMES as an adjunct to standard treatments, in patients following tracheotomy. Unit of Measure: the yale pharyngeal residue severity rating scale rated by a speech-language therapist based on fiberoptic endoscopic evaluation of swallowing (FEES). This assessments by a speech-language therapist blinded to group allocation.	21 days
Time to resume oral feeding at Day 21 after NMES initiation	Description: Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on time to resume oral feeding within 21 days in tracheotomized patients following prolonged mechanical ventilation weaning. Time will be measured in days. In routine practice, all changes in the patient's dietary intake are recorded daily by medical, dietitians and nursing staff. Data collected from the patient's electronic medical record by a clinical research technician.	At day 21 after initiation of NMES/placebo
Duration of mechanical ventilation	Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the duration of mechanical ventilation. Data collected from the patient's electronic medical record by a clinical research technician.	Day 21 after initiation of NMES treatment/placebo
Lenght of stay	Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on length of stay in the intensive care unit. Length of stay will be measured in days and collected from the electronic medical records by a trained clinical research technician.	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	Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on time to tracheotomy decannulation. Time will be measured in days. Data will be collected from the electronic medical records by a trained clinical research technician.	From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days)
Prevalence of malnutrition	Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the prevalence of malnutrition at Day 21. Prevalence of malnutrition will be expressed as a percentage of patients meeting predefined diagnostic criteria (French national recommendations on malnutrition diagnostic evaluation)	At day 21 after initiation NMES treament/place
Prevalence of malnutrition at unit discharge	Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the prevalence of malnutrition at unit discharge. Prevalence of malnutrition will be expressed as a percentage of patients meeting predefined diagnostic criteria (French national recommendations on malnutrition diagnostic evaluation)	At study end, defined as discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)

Collaborators and Investigators

• Sponsor: Hopital Forcilles
• Investigators: Principal Investigator: Carlos Diaz Lopez, Hopital Forcilles

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Deglutition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2024-A01576-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No