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

Deglutition Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01202968
• Other study ID #: chhwang2
• Status: Withdrawn
• Phase: N/A
• First received: September 15, 2010
• Last updated: December 22, 2013
• Start date: December 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deglutition Disorder
• Deglutition Disorders

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	oral transit time	oral transit time was measured through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No
Secondary	pharyngeal transit time	pharyngeal transit time was measured through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No
Secondary	oro-pharyngeal transit time	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	No
Secondary	swallowed volume	swallowd volume was measured through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No
Secondary	aspiration volume	aspiration volume was measured through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No
Secondary	presence of aspiration	presence of aspiration was checked through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No
Secondary	presence of silent aspiration	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	No
Secondary	penetration-aspiration scale	penetration-aspiration scale was scored through videofluoroscopic swallowing study	as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days	No