Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:09 AM
Study NCT ID:
NCT05098834
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Impedence Tomography With ENLIGHT2100
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Device received FDA approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in expiratory lung volume as measured by global lung electrical impedance', 'timeFrame': 'Baseline, 60 mins, 75 mins, 90 mins'}], 'secondaryOutcomes': [{'measure': 'Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance', 'timeFrame': 'Baseline, 60 mins, 75 mins, 90 mins'}, {'measure': 'Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance', 'timeFrame': 'Baseline, 60 mins, 75 mins, 90 mins'}, {'measure': 'Percent of failed extubation as measured by need for re-intubation', 'timeFrame': 'Within 24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Breathing tube', 'Mechanical ventilator'], 'conditions': ['Extubation']}, 'descriptionModule': {'briefSummary': 'Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.\n\nThe purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study\n\nExclusion Criteria:\n\n* Patients with corrected gestational age less than 37 weeks\n* Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)\n* known pregnancy\n* Patients previously enrolled in this study will be excluded from participation."}, 'identificationModule': {'nctId': 'NCT05098834', 'briefTitle': 'Electrical Impedence Tomography With ENLIGHT2100', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children', 'orgStudyIdInfo': {'id': 'Pro00108931'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PICU and PCICU Patients', 'description': 'Patients younger than 17 years of age receiving mechanical ventilation for an acute respiratory illness will be approached to participate prior to initiation of an ERT for clinical purposes.', 'interventionNames': ['Device: ENLIGHT 2100 ventilatory electrical impedance tomograph']}], 'interventions': [{'name': 'ENLIGHT 2100 ventilatory electrical impedance tomograph', 'type': 'DEVICE', 'description': 'The ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation.', 'armGroupLabels': ['PICU and PCICU Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Alexandre Rotta, MD, FCCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}