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

Primary Purpose

Deglutition Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcutaneous neuro-muscular electrical stimulation
Sponsored by
Ulsan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deglutition Disorder focused on measuring intubation electric stimulation deglutition disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University Hospital

Outcomes

Primary Outcome Measures

oro-pharyngeal swallowing efficiency
oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study

Secondary Outcome Measures

oral transit time
oral transit time was measured through videofluoroscopic swallowing study
pharyngeal transit time
pharyngeal transit time was measured through videofluoroscopic swallowing study
oro-pharyngeal transit time
oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study
swallowed volume
swallowd volume was measured through videofluoroscopic swallowing study
aspiration volume
aspiration volume was measured through videofluoroscopic swallowing study
presence of aspiration
presence of aspiration was checked through videofluoroscopic swallowing study
presence of silent aspiration
presence of silent aspiration was checked through videofluoroscopic swallowing study
penetration-aspiration scale
penetration-aspiration scale was scored through videofluoroscopic swallowing study

Full Information

First Posted
September 15, 2010
Last Updated
December 22, 2013
Sponsor
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01202968
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorder
Keywords
intubation electric stimulation deglutition disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transcutaneous neuro-muscular electrical stimulation
Other Intervention Name(s)
VitalStim (DJO Incorporated, California, USA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
oro-pharyngeal swallowing efficiency
Description
oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Secondary Outcome Measure Information:
Title
oral transit time
Description
oral transit time was measured through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
pharyngeal transit time
Description
pharyngeal transit time was measured through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
oro-pharyngeal transit time
Description
oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
swallowed volume
Description
swallowd volume was measured through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
aspiration volume
Description
aspiration volume was measured through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
presence of aspiration
Description
presence of aspiration was checked through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
presence of silent aspiration
Description
presence of silent aspiration was checked through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Title
penetration-aspiration scale
Description
penetration-aspiration scale was scored through videofluoroscopic swallowing study
Time Frame
as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of

12. IPD Sharing Statement

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

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