Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT06299904
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the score of Fiberoptic endoscopic examination of swallowing (FEES)', 'timeFrame': '2 weeks', 'description': 'Fiberoptic endoscopic examination of swallowing'}, {'measure': "the score of Murray's secretion scale (MSS)", 'timeFrame': '2 weeks', 'description': 'MSS'}, {'measure': 'the score of penetration-aspiration scale (PAS)', 'timeFrame': '2 weeks', 'description': 'PAS'}], 'secondaryOutcomes': [{'measure': 'the score of Clinical Pulmonary Infection Score (CPIS)', 'timeFrame': '2 weeks', 'description': 'CPIS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;\n* patients with relatively stable vital signs, with a NIHSS score of 21 points;\n* patients with tracheotomy accompanied by dysphagia;\n* no previous history of dysphagia;\n* age ≥ 30 years and ≤80 years;\n* informed consent signed by the patient and his family.\n\nExclusion Criteria:\n\n* patients with medullary haemorrhage/infarction;\n* patients that experienced cerebral hernia and recurrent stroke;\n* patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;\n* patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;\n* patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;\n* patients with a history of epilepsy or risk of seizures.'}, 'identificationModule': {'nctId': 'NCT06299904', 'briefTitle': 'Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Dalian Medical University'}, 'officialTitle': 'Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke', 'orgStudyIdInfo': {'id': 'stroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.', 'interventionNames': ['Behavioral: Conventional air-pulse stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'trial group', 'description': 'The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.', 'interventionNames': ['Behavioral: Modified Air-pulse Stimulation']}], 'interventions': [{'name': 'Modified Air-pulse Stimulation', 'type': 'BEHAVIORAL', 'description': 'Connected the oxygen humidification bottle to a fibreoptic endoscope, then inserted the terminal into the nasal cavity and the pulse sensation stimulation generated by oxygen was transmitted through the internal port of the fibreoptic endoscope to the anterior wall of the pyriform recess or to the folds of the arytenoepiglottis. (5 min once a day for 2 weeks)', 'armGroupLabels': ['trial group']}, {'name': 'Conventional air-pulse stimulation', 'type': 'BEHAVIORAL', 'description': "The terminal airway of the air pulse was placed in the oral cavity, specifically in the patient's palatoglossal arch, pharyngeal posterior wall, tongue base, and other areas. The airbag was quickly squeezed to generate airflow and stimulate the mucosa.(5 min once a day for 2 weeks)", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116024', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wuyao Pan, postgraduate', 'role': 'CONTACT', 'email': '331189506@qq.com', 'phone': '+86-18186766836'}], 'facility': 'the Second Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}