Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06000618
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intrapulmonary Percussive Ventilator on Respiratory Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function test', 'timeFrame': 'through study completion, an average one hour', 'description': "This test can assess the volunteer's lung ventilation and diffusion function.For example the max vital capacity (VCMAX),Forced vital capacity(FVC),Forced expiratory volume in one second(FEV1),functional residual capacity(FRC-SB),diffusion capacity of lung for carbon monoxide(DLCO) and so on."}, {'measure': 'Electrical Impedance Tomography of Pulmonary(EIT)', 'timeFrame': 'through study completion, an average one hour', 'description': 'EIT is a relatively advanced non-invasive monitoring technique for the lung function. This technology uses a strap attached to the chest to monitor electrical at 16 locations. The Ventilation in each area resistance of the lung is quantified according to the electrical resistance'}], 'secondaryOutcomes': [{'measure': 'The safety and comfort', 'timeFrame': 'The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.', 'description': 'Whether the technique has adverse reactions. How do the volunteers feel? We used a scale of 1 to 4 to show how the volunteers felt. 1 is the worst feeling. The volunteers were no longer willing to undergo the treatment. 4 means the volunteers felt better and breathed easier after the treatment. Be willing to undergo endoairway shock therapy again.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrapulmonary percussive', 'Healthy volunteer', 'pulmonary function', 'Electrical Impedance Tomography'], 'conditions': ['Airway Clearance Impairment']}, 'referencesModule': {'references': [{'pmid': '34025750', 'type': 'BACKGROUND', 'citation': 'Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.'}, {'pmid': '27827332', 'type': 'RESULT', 'citation': 'Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are:\n\n* How can intrapulmonary percussive improve lung function？\n* What is the subjective feeling through intrapulmonary percussive?\n\nParticipants will be undergoing treatment of intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* No respiratory system, heart disease\n* Well cooperate with the MateNeb\n\nExclusion Criteria:\n\n* No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month\n* Couldn't finish three times pulmonary function test"}, 'identificationModule': {'nctId': 'NCT06000618', 'briefTitle': 'Effects of Intrapulmonary Percussive Ventilator on Respiratory Function', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'STPH-ICU-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'The experimental group will undergo intrapulmonary percussive therapy', 'interventionNames': ['Device: Intrapulmonary Percussive ventilator']}], 'interventions': [{'name': 'Intrapulmonary Percussive ventilator', 'type': 'DEVICE', 'otherNames': ['MateNeb'], 'description': 'The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Xin Jing, Dr', 'role': 'CONTACT', 'email': 'lingzi_jx@163.com', 'phone': '+8618917682679'}, {'name': 'Xing Qi Wang, Dr', 'role': 'CONTACT', 'email': 'wangqixing1221@163.com', 'phone': '+8618917683119'}, {'name': 'Sheng Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xin Jing, Dr', 'role': 'CONTACT', 'email': 'lingzi_jx@163.com', 'phone': '+86-18917682679'}, {'name': 'Xing Qi Wang, Dr', 'role': 'CONTACT', 'email': 'wangqixing1221@163.com', 'phone': '+86-18917683119'}], 'overallOfficials': [{'name': 'Sheng Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Sheng Wang MD PhD', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}