Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-03-12 @ 2:13 AM
Study NCT ID:
NCT03284892
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2017-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Intervention of Postextubation Dysphagia
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': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resumption of oral feeding', 'timeFrame': 'Postextubation 7 days', 'description': 'Measured by Functional Oral Intake Scale'}, {'measure': 'Incidence of penetration and aspiration', 'timeFrame': 'Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation', 'description': 'Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.'}, {'measure': 'Incidence of pneumonia', 'timeFrame': 'Postextubation 30 days', 'description': 'Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.'}], 'secondaryOutcomes': [{'measure': 'Incidence of feeding tube dependency', 'timeFrame': 'Postextubation 30 days', 'description': 'Abstracted from electronic medical records'}, {'measure': 'Unstimulated salivary flow rate (centimeter/5 minutes)', 'timeFrame': 'Time points of assessments: within 48 hours postextubation and at the day 10 postextubation', 'description': 'Measured by the whatman 41 test strip'}, {'measure': 'Oral health status score', 'timeFrame': 'Time points of assessments: within 48 hours postextubation and at the day 10 postextubation', 'description': 'Measured by the oral Assessment Guide'}, {'measure': 'Lip closure and lingual diadochokinetic status', 'timeFrame': 'Time points of assessments: within 48 hours postextubation and at the day 10 postextubation', 'description': 'Measured by the Frenchay Dysarthria Assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postextubation dysphagia', 'endotracheal intubation', 'randomized controlled trial', 'dysphagia intervention', 'dysphagia screening'], 'conditions': ['Oropharyngeal Dysphagia', 'Swallowing Disorder', 'Randomized Controlled Trial', 'Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '37438759', 'type': 'DERIVED', 'citation': 'Siao SF, Ku SC, Tseng WH, Wei YC, Chang YC, Hsiao TY, Wang TG, Chen CC. Effects of a swallowing and oral-care program on resuming oral feeding and reducing pneumonia in patients following endotracheal extubation: a randomized, open-label, controlled trial. Crit Care. 2023 Jul 12;27(1):283. doi: 10.1186/s13054-023-04568-6.'}, {'pmid': '34872549', 'type': 'DERIVED', 'citation': 'Siao SF, Tseng WH, Wang TG, Wei YC, Hsiao TY, Ku SC, Chen CC. Predicting feeding-tube dependence in patients following endotracheal extubation: a two-item swallowing screen. BMC Pulm Med. 2021 Dec 6;21(1):403. doi: 10.1186/s12890-021-01771-5.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.', 'detailedDescription': 'Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is over 20 years old.\n* Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.\n\nExclusion Criteria:\n\n* Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.\n* Patient who has preexisting difficulty swallowing.\n* Patient who has received a tracheostomy.\n* Patient who were unable to follow verbal instructions.\n* Patient who were on contact and droplet precautions (e.g., open tuberculosis)\n* Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention'}, 'identificationModule': {'nctId': 'NCT03284892', 'briefTitle': 'Screening and Intervention of Postextubation Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia', 'orgStudyIdInfo': {'id': '201705051RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOC group', 'description': 'Received SOC program addition to usual care', 'interventionNames': ['Behavioral: SOC program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Received usual care only'}], 'interventions': [{'name': 'SOC program', 'type': 'BEHAVIORAL', 'description': 'A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.', 'armGroupLabels': ['SOC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10055', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Cheryl Chia-Hui Chen, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, College of Medicine, National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}