Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-27 @ 5:11 PM
Study NCT ID:
NCT01202968
Status:
WITHDRAWN
Last Update Posted:
2013-12-24
First Post:
2010-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-22', 'studyFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oro-pharyngeal swallowing efficiency', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'oro-pharyngeal swallowing efficiency was calculated by using the data derived from videofluoroscopic swallowing study'}], 'secondaryOutcomes': [{'measure': 'oral transit time', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'oral transit time was measured through videofluoroscopic swallowing study'}, {'measure': 'pharyngeal transit time', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'pharyngeal transit time was measured through videofluoroscopic swallowing study'}, {'measure': 'oro-pharyngeal transit time', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'oro-pharyneal transit time was calculated by using the data derived from videofluoroscopic swallowing study'}, {'measure': 'swallowed volume', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'swallowd volume was measured through videofluoroscopic swallowing study'}, {'measure': 'aspiration volume', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'aspiration volume was measured through videofluoroscopic swallowing study'}, {'measure': 'presence of aspiration', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'presence of aspiration was checked through videofluoroscopic swallowing study'}, {'measure': 'presence of silent aspiration', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'presence of silent aspiration was checked through videofluoroscopic swallowing study'}, {'measure': 'penetration-aspiration scale', 'timeFrame': 'as soon as patient could tolerate videofluoroscopic swallowing study after extubation; average of 5 days', 'description': 'penetration-aspiration scale was scored through videofluoroscopic swallowing study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intubation electric stimulation deglutition disorder'], 'conditions': ['Deglutition Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nPreemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious cycle of dis-use was reported to improve dysphagia after extubation.\n\nNeuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of multiple causes of neuro-muscular disorder.\n\nSupposing 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients to be admitted to the ICU due to the respiratory failure and intubated for at least 48 hours\n\nExclusion Criteria:\n\n* Past history of intubation\n* Past history or current status of traumatic brain injury\n* Past history or current status of symptomatic stroke\n* Past history or current status of injury of cranial nerves\n* Past history or current status of neuromuscular disorder\n* Patient not to be expected to be extubated\n* Patient to reject the participation\n* current usage of neuro-muscular blockers'}, 'identificationModule': {'nctId': 'NCT01202968', 'briefTitle': 'Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients', 'orgStudyIdInfo': {'id': 'chhwang2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcutaneous neuro-muscular electrical stimulation', 'type': 'PROCEDURE', 'otherNames': ['VitalStim (DJO Incorporated, California, USA)'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}