Deglutition DisorderNCT01202968
Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
A study testing Transcutaneous neuro-muscular electrical stimulation in people with Deglutition Disorder, run by Ulsan University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deglutition Disorder
- What is being tested?
- Transcutaneous neuro-muscular electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Transcutaneous neuro-muscular electrical stimulation
- Keywords
- intubation electric stimulation deglutition disorder
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous neuro-muscular electrical stimulationProcedure or surgery
Also called VitalStim (DJO Incorporated, California, USA)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
oro-pharyngeal swallowing efficiency
oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Secondary outcomes (8)
oral transit time
oral transit time was measured through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
pharyngeal transit time
pharyngeal transit time was measured through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
oro-pharyngeal transit time
oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
swallowed volume
swallowd volume was measured through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
aspiration volume
aspiration volume was measured through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
presence of aspiration
presence of aspiration was checked through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
presence of silent aspiration
presence of silent aspiration was checked through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
penetration-aspiration scale
penetration-aspiration scale was scored through videofluoroscopic swallowing study
Measured: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Study director, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202968
- Sponsor's protocol ID
- chhwang2
- Status last verified
- Dec 2013
- First submitted
- 15 Sep 2010
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
- ClinicalTrials.gov ID
- NCT01202968
- Acronym / sponsor ID
- chhwang2
- Conditions
- Deglutition Disorder
- Keywords
- intubation electric stimulation deglutition disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous neuro-muscular electrical stimulationAlso: VitalStim (DJO Incorporated, California, USA)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. | Procedure or surgery | – |
Primary outcome
oro-pharyngeal swallowing efficiency
Time frame: 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
8 secondary outcomes
oral transit time
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
pharyngeal transit time
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
oro-pharyngeal transit time
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
swallowed volume
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
aspiration volume
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
presence of aspiration
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
presence of silent aspiration
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
penetration-aspiration scale
Time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Ho Hwang, M.D. study director
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous neuro-muscular electrical stimulation in people with Deglutition Disorder, run by Ulsan University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oro-pharyngeal swallowing efficiency (time frame: as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.