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

NCT01202968 | Withdrawn DMC

• 1 other identifier: chhwang2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorder

Keywords

intubation electric stimulation deglutition disorder

Outcome Measures

Primary Outcomes (1)

• oro-pharyngeal swallowing efficiency

  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 Outcomes (8)

• oral transit time

  as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

• pharyngeal transit time

  as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

• oro-pharyngeal transit time

  as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

• swallowed volume

  as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

• aspiration volume

  as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days

Interventions

Transcutaneous neuro-muscular electrical stimulation PROCEDURE

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.

Also known as: VitalStim (DJO Incorporated, California, USA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulsan University Hospital: lead

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chang Ho Hwang, M.D.

  Ulsan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

KR (1)