Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 7:53 PM
Study NCT ID:
NCT06372795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Swallowing Training in Patients With Tracheotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced swallowing tongue pressure', 'timeFrame': 'Day 14 after training', 'description': "Place the pressure balloon on the prelingual pressure measurement site. The examiner placed the water in the participant 's mouth using a disposable 3 mL syringe. Subjects held 3 mL of water in their mouth and swallowed as forcefully as possible as directed by the examiner to observe instrument readings."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Training on Muscle Strength']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:\n\n* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?\n* What medical problems do participants have when taking swallowing training?\n\nResearchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.\n\nParticipants will:\n\n-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Tracheotomy after intubation and ventilator ventilation\n* Receiving treatment in ICU, and expected hospital stay \\> 2 weeks after pneumonectomy\n* Be able to cooperate to complete the maximum anterior tongue pressure test\n\nExclusion Criteria:\n\n* Inability to cooperate with tongue pressure testing and swallowing training, including disturbance of consciousness, oropharyngeal neuromuscular or motor impairment\n* Patients refuse to participate in this study\n* Significant malocclusion and facial asymmetry'}, 'identificationModule': {'nctId': 'NCT06372795', 'briefTitle': 'Resistance Swallowing Training in Patients With Tracheotomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Effect of Early Progressive Resistance Swallowing Training on Swallowing Related Muscle Strength in Patients With Tracheotomy', 'orgStudyIdInfo': {'id': 'KY2023635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: pure effortful swallowing']}, {'type': 'EXPERIMENTAL', 'label': 'Test group', 'interventionNames': ['Other: progressive resistance swallowing training']}], 'interventions': [{'name': 'pure effortful swallowing', 'type': 'OTHER', 'description': 'The investigator instructed the patient to "swallow forcefully while squeezing the tongue upward and backward in the direction of the soft palate" based on the sounds of an electronic timer.', 'armGroupLabels': ['Control group']}, {'name': 'progressive resistance swallowing training', 'type': 'OTHER', 'description': 'Patients in the test group, resistance swallowing exercise was performed by providing external resistance through Iowa Oral Performance Instrument (IOPI), and all other protocols were performed the same as those in the control group.', 'armGroupLabels': ['Test group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}