Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-10 @ 9:10 AM
Study NCT ID:
NCT06386159
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional oral intake scale（FOIS）', 'timeFrame': 'up to 90 days', 'description': 'FOIS consists of seven levels: ① Score 1, unable to eat orally at all; ② Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ③ Score 3, dependent on tube feeding, taking single texture food or liquid orally; ④ Score 4, completely oral intake of single texture food; ⑤ score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ⑥6 points, completely oral feeding without special preparation, but with special food restriction; ⑦7 points, complete oral feeding without restriction, the higher the score, the better the swallowing function of the patient. In this study, a FOIS score of 6-7 was defined as full oral feeding'}, {'measure': 'standardized Swallowing Assessment（SSA）', 'timeFrame': 'up to 90 days', 'description': "The first part is the clinical examination.The second part involves observing the patient's ability to swallow 5 mL of water, repeated three times. If there are no abnormalities detected in the above examinations, the amount of water for swallowing is then increased to 60 mL. To obtain the total score, the scores from all three parts are summed up."}], 'secondaryOutcomes': [{'measure': 'Rate of total oral feeding after the intervention', 'timeFrame': 'up to 90 days', 'description': "After the intervention, the patient's score on the Functional Oral Intake Scale (FOIS) was between 6 and 7, indicating that the patient has recovered the ability to eat orally."}, {'measure': 'Duration of Enteral Nutrition Tube Indwelling', 'timeFrame': 'up to 90 days', 'description': 'The duration of the nasogastric tube or nasointestinal tube indwelling in the patient'}, {'measure': 'Rate of Re-intubation after Endotracheal Intubation', 'timeFrame': 'up to 90 days', 'description': 'The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation'}, {'measure': 'Incidence of aspiration within one week after extubation', 'timeFrame': 'up to 90 days', 'description': 'Incidence of aspiration within one week after extubation'}, {'measure': 'The incidence of aspiration pneumonia within one week after extubation', 'timeFrame': 'up to 90 days', 'description': 'The incidence of aspiration pneumonia within one week after extubation'}, {'measure': 'Inflammation-related indicators: serum C-reactive protein (CRP)', 'timeFrame': 'up to 90 days', 'description': "Monitoring of patients' inflammatory marker"}, {'measure': 'Inflammation-related indicators: serum interleukin-6 (IL-6)', 'timeFrame': 'up to 90 days', 'description': "Monitoring of patients' inflammatory marker"}, {'measure': 'Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)', 'timeFrame': 'up to 90 days', 'description': "Monitoring of patients' inflammatory markers"}, {'measure': 'Inflammation-related indicators: high mobility group box-1 protein (HMGB1)', 'timeFrame': 'up to 90 days', 'description': "Monitoring of patients' inflammatory marker"}, {'measure': 'Days of ICU hospitalization', 'timeFrame': 'up to 90 days', 'description': 'Days of ICU hospitalization'}, {'measure': 'Total days of hospitalization', 'timeFrame': 'up to 90 days', 'description': 'Total days of hospitalization'}, {'measure': 'In-hospital survival rate', 'timeFrame': 'up to 90 days', 'description': 'The number of patients who survive during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-extubation dysphagia, electrical stimulation'], 'conditions': ['Post-extubation Dysphagia']}, 'descriptionModule': {'briefSummary': 'This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who met the diagnostic criteria of PED were changed to SSA score ≥24\n2. aged from 18 to 90 years old;\n3. oral or nasotracheal intubation for ≥48 hours;\n4. Clear mind\n5. Glasgow score ≥13 points, with good cooperation ability;\n6. There was no contraindication to oral feeding after extubation\n\nExclusion Criteria:\n\n1. Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.);\n2. history of reflux and aspiration;\n3. tracheotomy;\n4. isolation treatment due to respiratory infectious diseases;\n5. the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);\n6. Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury"}, 'identificationModule': {'nctId': 'NCT06386159', 'briefTitle': 'Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism', 'orgStudyIdInfo': {'id': '2023-1178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'During routine medical care and nursing, the responsible nurse provides daily oral care and delivers health education to patients and their caregivers regarding diet and swallowing safety. Within 8 hours after the removal of the endotracheal tube, the Standardized Swallowing Assessment (SSA) is used to screen for swallowing function. Patients are guided in food selection based on the severity of their swallowing difficulties and personal preferences, and are supplemented with enteral or parenteral nutrition or prescribed specific diets as directed by their doctor.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comprehensive Intervention Group', 'description': "On the basis of the control group, a comprehensive intervention plan determined through Delphi expert consultation is implemented for PED patients. This plan includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. The duration and frequency of the exercises are tailored to the patient's actual condition.", 'interventionNames': ['Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Comprehensive Intervention Combined with Vagus Nerve Stimulation Group', 'description': 'On the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation.', 'interventionNames': ['Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation']}], 'interventions': [{'name': 'Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation', 'type': 'OTHER', 'description': 'Comprehensive intervention includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. Transcutaneous electrical stimulation of the vagus nerve at the lateral neck was performed by rehabilitation therapists. The cervical vagus nerve accompanies the carotid artery and is located at the groove between the trachea and the sternocleidomastoid muscle, which can be located by touching the carotid pulse. The two electrodes were pasted along the path of the cervical vagus nerve.', 'armGroupLabels': ['Comprehensive Intervention Combined with Vagus Nerve Stimulation Group', 'Comprehensive Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinhua', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiping Xu', 'role': 'CONTACT', 'email': '240931013@qq.com', 'phone': '13506587812'}], 'facility': 'Jinhua Municipal Central Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}], 'centralContacts': [{'name': 'Xiuqin Feng', 'role': 'CONTACT', 'email': 'fengxiuqin@zju.edu.cn', 'phone': '13757119151'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinhua Municipal Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}