Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients

Study Overview
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Brief Summary
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It was well known that long term intubation caused a various kind of abnormal presentations of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal pathology, the airway stenosis and so on. It was thought that the freezing and impaired proprioception to be developed as a result of dis-use around the pharynx and the larynx while intubation was one of the reason. Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious cycle of dis-use was reported to improve dysphagia after extubation. Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of multiple causes of neuro-muscular disorder. Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered to the muscles of being involved in swallowing could decrease the degree of dis-use during intubation so that it could reduce the occurence and severity of dysphagia developed after extubation, the investigators plan to perform randomized prospective double blind placebo controlled clinical interventional study.

Official Title
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Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients

Conditions
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Deglutition Disorder

Intervention / Treatment
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* Procedure: Transcutaneous neuro-muscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours Exclusion Criteria: Past history of intubation Past history or current status of traumatic brain injury Past history or current status of symptomatic stroke Past history or current status of injury of cranial nerves Past history or current status of neuromuscular disorder Patient not to be expected to be extubated Patient to reject the participation current usage of neuro-muscular blockers
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transcutaneous neuro-muscular electrical stimulation|Neuro-muscular electrical stimulation with two pairs of surface electrodes was applied to submental area. One paired electrodes to be placed horizontally was attached on the anterior half of area between mandible and hyoid bone. The other was affixed to posterior half of the same area far laterally. Bipolar electrical stimulation with pulse rate of 80-Hz, duration of 700 µs and intensity to evoke visible muscle contraction was performed for 60 minutes a day until one day before extubation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oro-pharyngeal swallowing efficiency | oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral transit time | oral transit time was measured through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| pharyngeal transit time | pharyngeal transit time was measured through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| oro-pharyngeal transit time | oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| swallowed volume | swallowd volume was measured through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| aspiration volume | aspiration volume was measured through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| presence of aspiration | presence of aspiration was checked through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| presence of silent aspiration | presence of silent aspiration was checked through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 
| penetration-aspiration scale | penetration-aspiration scale was scored through videofluoroscopic swallowing study | as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation electric stimulation deglutition disorder