Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05873504
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2023-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome Comparisons of Vibratory Airway Clearance Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-22', 'size': 190619, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-16T10:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory assess and treat (RAAT) score', 'timeFrame': 'Change from baseline RAAT score at 12 hours', 'description': 'The RAAT score range from 0-50.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Clearance Impairment']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.', 'detailedDescription': 'This pilot study is a randomized control trial of adult patients admitted to an academic medical center. Subjects included in this study must be adults 18 years or older and will receive a respiratory assessment and allocation of therapy (RAAT) score of at least 10 and a secretion score of at least 5. Exclusion criteria include those younger than 18 years of age, those who are pregnant, with an SVC of \\<10mL/kg, and who cannot follow instructions or currently receiving cough assist, vest or intrapulmonary percussive ventilation. Patients receiving more than one therapy session using the oscillatory index device before enrollment will be excluded. Patients with multiple ICU admissions will be enrolled once. After randomization, the study team will give the device to the patient and administer instructions on the device use. Each eligible patient will receive clinical evaluation using RAAT scores per the department policy. The frequency of using oscillatory index devices will be based on the department protocol. Each subject will be followed up until discharge from the hospital. The primary outcome will be the RAAT score. The RAAT score range from 0-50 and includes five components: respiratory rate, oxygen therapy, chest x-ray, secretion clearance, and vital capacity. The higher score denotes respiratory compromise, and therapy is assigned for score 10 or greater per departmental protocol. The secondary outcomes include respiratory interventions used or other bronchial hygiene (vest therapy, intrapulmonary percussive ventilation) performed, ICU re-admission, need for continuous positive pressure, and length of stay (hospital and ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years or older\n* Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Pregnant\n* Slow vital capacity (SVC) of \\<10 mL/kg\n* Unable to follow instructions\n* Currently receiving cough assist, vest therapy or intrapulmonary percussive ventilation\n* Received more than 1 therapy session using oscillatory index device\n* Multiple ICU admission with previous study enrollment'}, 'identificationModule': {'nctId': 'NCT05873504', 'briefTitle': 'Outcome Comparisons of Vibratory Airway Clearance Devices', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Outcome Comparisons of Two Vibratory Positive Expiratory Pressure Devices in Patients Unable to Clear Airway Secretions', 'orgStudyIdInfo': {'id': '23011705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Oscillatory Index Device', 'description': 'Patients in this arm will receive a device that vibrates with high oscillatory index.', 'interventionNames': ['Device: High Oscillatory Index Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Oscillatory Index Device', 'description': 'Patients in this arm will receive a device that vibrates with low oscillatory index.', 'interventionNames': ['Device: Low Oscillatory Index Device']}], 'interventions': [{'name': 'High Oscillatory Index Device', 'type': 'DEVICE', 'otherNames': ['Aerobika'], 'description': 'This device is commonly used to provide assistance with airway secretion clearance.', 'armGroupLabels': ['High Oscillatory Index Device']}, {'name': 'Low Oscillatory Index Device', 'type': 'DEVICE', 'otherNames': ['VibraPEP'], 'description': 'This device is commonly used to provide assistance with airway secretion clearance.', 'armGroupLabels': ['Low Oscillatory Index Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Vines, PhD', 'role': 'CONTACT'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'David Vines, PhD', 'role': 'CONTACT', 'email': 'David_Vines@rush.edu', 'phone': '312-942-4408'}, {'name': 'Lauren Harnois, MSc', 'role': 'CONTACT', 'email': 'Lauren_J_Harnois@rush.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}