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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:
Sponsor: Ulsan University Hospital

Current Primary Outcome: oro-pharyngeal swallowing efficiency [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • oral transit time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ]
    penetration-aspiration scale was scored through videofluoroscopic swallowing study


Original Secondary Outcome: Same as current

Information By: Ulsan University Hospital

Dates:
Date Received: September 15, 2010
Date Started: December 2010
Date Completion: October 2012
Last Updated: December 22, 2013
Last Verified: December 2013