Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT05041894
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm excursion', 'timeFrame': 'Half an hour', 'description': 'The measurement of the diaphragm dome excursion following the M-mode approach during quiet breathing could provide indirect information about inspiratory volume.'}, {'measure': 'Diaphragm thickness', 'timeFrame': 'Half an hour', 'description': 'The diaphragm thickness was measured by B-mode approach providing clear visualization of the diaphragm morphology at the zone of apposition at the quiet breathing on the three tilting.'}], 'secondaryOutcomes': [{'measure': 'The intraclass correlation coefficient (ICC)', 'timeFrame': 'Within-24h', 'description': 'For the ultrasonography assessment, the intraclass correlation coefficient (ICC) was analyzed by using the two-way mixed-effects ICC \\[2.1\\] model with 95% confidence intervals (CIs).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['The stroke patients with tracheotomy', 'Diaphragm excursion', 'Diaphragm thickness', 'Ultrasonography'], 'conditions': ['Stroke', 'Diaphragm Injury', 'Tracheostomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine whether if the effect of standing with assistance of the tilt table on diaphragm excursion and thickness in the stroke patients with tracheotomy.', 'detailedDescription': '40-45 stroke patients with tracheotomy were passive tilting (α=0°, 30°, 60°) by an electric tilt table in the random order. The diaphragm excursion and thickness were measured by ultrasonography on three tilting during the quiet breathing. Besides, the intraclass correlation coefficient (ICC) were calculated to assess the reliability of the diaphragm ultrasonography in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. currently diagnosed with ischemic or hemorrhagic stroke by CT or MRI;\n2. right unilateral or bilateral limb with hemiparesis;\n3. age over 18 years;\n4. BMI\\<35 kg/m2;\n5. within 2 weeks to 12 months；\n6. the tracheotomy tube replacement;\n7. non first time standing assisted with tilt table.\n\nExclusion Criteria:\n\n1. undergoing mechanical ventilation;\n2. postural hypotension;\n3. myocardial infarction in the first 3 months;\n4. deep vein thrombosis;\n5. angina or acute heart failure;\n6. complicated with other primary pulmonary diseases, such as tuberculosis,；pneumothorax, and chronic obstructive pulmonary disease and so on;\n7. a past episode of abdominal or chest surgery.'}, 'identificationModule': {'nctId': 'NCT05041894', 'briefTitle': 'Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen Second People's Hospital"}, 'officialTitle': 'Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke With Tracheotomy : Assessment by Ultrasonography', 'orgStudyIdInfo': {'id': '20210309002-FS01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tilt table', 'type': 'OTHER', 'otherNames': ['diaphragm ultrasonography'], 'description': 'The tilt table provides passive standing for the stroke patients with tracheotomy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'country': 'China', 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}