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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, Ulsan University Hospital
ClinicalTrials.gov Identifier:
NCT01202968
First received: September 15, 2010
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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 Intervention
Deglutition Disorder
Procedure: Transcutaneous neuro-muscular electrical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients

Resource links provided by NLM:


Further study details as provided by Ulsan University Hospital:

Primary Outcome Measures:
  • oro-pharyngeal swallowing efficiency [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study


Secondary Outcome Measures:
  • oral transit time [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    oral transit time was measured through videofluoroscopic swallowing study

  • pharyngeal transit time [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    pharyngeal transit time was measured through videofluoroscopic swallowing study

  • oro-pharyngeal transit time [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study

  • swallowed volume [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    swallowd volume was measured through videofluoroscopic swallowing study

  • aspiration volume [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    aspiration volume was measured through videofluoroscopic swallowing study

  • presence of aspiration [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    presence of aspiration was checked through videofluoroscopic swallowing study

  • presence of silent aspiration [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    presence of silent aspiration was checked through videofluoroscopic swallowing study

  • penetration-aspiration scale [ Time Frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days ] [ Designated as safety issue: No ]
    penetration-aspiration scale was scored through videofluoroscopic swallowing study


Enrollment: 0
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: VitalStim (DJO Incorporated, California, USA)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202968

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Chang Ho Hwang, Clinical Associate Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT01202968     History of Changes
Other Study ID Numbers: chhwang2
Study First Received: September 15, 2010
Last Updated: December 22, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Ulsan University Hospital:
intubation electric stimulation deglutition disorder

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014