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

December 22, 2013 updated by: Chang Ho Hwang, Ulsan University Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
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
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulsan University Hospital

Investigators

  • Study Director: Chang Ho Hwang, M.D., Ulsan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 22, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chhwang2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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