Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 1:15 AM
Study NCT ID:
NCT02878993
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Infant Extubation Using Diaphragm Surface Electromyography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of diaphragm EMG', 'timeFrame': 'One hour', 'description': 'Magnitude of diaphragm EMG'}, {'measure': 'Ratio of diaphragm EMG to tidal volume', 'timeFrame': 'One hour', 'description': 'Ratio of diaphragm EMG to tidal volume'}], 'secondaryOutcomes': [{'measure': 'Extubation success', 'timeFrame': '48 hours', 'description': 'Extubation success is define as remaining free of invasive mechanical ventilation. Whether the above measures of diaphragm EMG can predict such success will be investigated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant, Newborn, Disease']}, 'referencesModule': {'references': [{'pmid': '32598319', 'type': 'BACKGROUND', 'citation': 'Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)', 'detailedDescription': 'This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants mechanically ventilated on NICU without major congenital abnormalities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intubated and mechanically ventilated on NICU\n\nExclusion Criteria:\n\n* major congenital abnormalities'}, 'identificationModule': {'nctId': 'NCT02878993', 'acronym': 'EMG', 'briefTitle': 'Predicting Infant Extubation Using Diaphragm Surface Electromyography', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Predicting Infant Extubation Using Diaphragm Surface Electromyography', 'orgStudyIdInfo': {'id': 'KCH16-100'}, 'secondaryIdInfos': [{'id': '16/LO/1281', 'type': 'OTHER', 'domain': 'NHS REC'}, {'id': '205807', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intubated infants', 'description': 'Recording of diaphragm EMG', 'interventionNames': ['Device: Recording of diaphragm EMG']}], 'interventions': [{'name': 'Recording of diaphragm EMG', 'type': 'DEVICE', 'description': 'Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography', 'armGroupLabels': ['Intubated infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE59RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anne Greenough', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}