---
title: Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
nct_id: NCT01202968
overall_status: WITHDRAWN
phase: NA
sponsor: Ulsan University Hospital
study_type: INTERVENTIONAL
primary_condition: Deglutition Disorder
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01202968.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01202968"
ct_last_update_post_date: 2013-12-24
last_seen_at: "2026-05-12T06:03:38.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients

**NCT ID:** [NCT01202968](https://clinicaltrials.gov/study/NCT01202968)

## Key Facts

- **Status:** WITHDRAWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Ulsan University Hospital
- **Conditions:** Deglutition Disorder
- **Start Date:** 2010-12
- **Completion Date:** 2012-10
- **CT.gov Last Update:** 2013-12-24

## 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.

## Eligibility

- **Sex:** ALL
- **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
```

## 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.

## Primary Outcomes

- **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

## 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)_

## Locations (1)

- Ulsan University Hospital, Ulsan, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ulsan university hospital|ulsan||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01202968.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01202968*  
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