Clinical trial NCT01202968: Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
Official title: Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Deglutition Disorder
Keywords: intubation electric stimulation deglutition disorder
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: oro-pharyngeal swallowing efficiency
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Secondary outcomes:
measure: oral transit time
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: pharyngeal transit time
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: oro-pharyngeal transit time
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: swallowed volume
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: aspiration volume
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: presence of aspiration
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: presence of silent aspiration
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
measure: penetration-aspiration scale
timeFrame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D.
role: STUDY_DIRECTOR
References: