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

Not Applicable

Withdrawn

• Conditions: Deglutition Disorder

• Registration Number: NCT01202968
• Lead Sponsor: Ulsan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-12
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-22
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of