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

Official title

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

Overview

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.

Interventions

• 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 s
• 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

Primary outcome measures

• 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 [Time frame: after 21 days of treatment]

Secondary outcome measures (7)

• Severity of swallowing disorders - the yale pharyngeal residue severity rating scale [Time frame: 21 days]
• Time to resume oral feeding at Day 21 after NMES initiation [Time frame: At day 21 after initiation of NMES/placebo]
• Duration of mechanical ventilation [Time frame: Day 21 after initiation of NMES treatment/placebo]
• Lenght of stay [Time frame: 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 [Time frame: From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days)]
• Prevalence of malnutrition [Time frame: At day 21 after initiation NMES treament/place]
• Prevalence of malnutrition at unit discharge [Time frame: At study end, defined as discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07529210 · 2024-A01576-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗