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

NCT ID: NCT01202968

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-10-31

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.

Detailed Description

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Conditions

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Deglutition Disorder

Keywords

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intubation electric stimulation deglutition disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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VitalStim (DJO Incorporated, California, USA)

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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chhwang2

Identifier Type: -

Identifier Source: org_study_id