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

• Sponsor: Ulsan University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01202968
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Deglutition Disorder	Procedure: Transcutaneous neuro-muscular electrical stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Sep 1, 2012
• Anticipated Study Completion Date: Oct 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ulsan University Hospital	Ulsan		Korea, Republic of	682-714

Sponsors and Collaborators

• Ulsan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Ho Hwang, Clinical Associate Professor, Ulsan University Hospital
• ClinicalTrials.gov Identifier: NCT01202968
• Other Study ID Numbers: chhwang2
• First Posted: Sep 16, 2010
• Last Update Posted: Dec 24, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Chang Ho Hwang, Clinical Associate Professor, Ulsan University Hospital: intubation electric stimulation deglutition disorder
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Dec 24, 2013