Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-04-23 @ 1:58 PM
Study NCT ID:
NCT03129802
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of extubation', 'timeFrame': 'need for a new intubation within the first 48 hours after extubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['extubation', 'pediatric resuscitation', 'reintubation', 'failures of extubation.', 'Respiratory Insufficiency'], 'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test.\n\nAlso pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.\n* Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.\n\nExclusion Criteria:\n\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03129802', 'briefTitle': 'Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'orgStudyIdInfo': {'id': '6310'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie Guilbert, MD', 'role': 'CONTACT', 'email': 'anne-sophie.guilbert@chru-strasbourg.fr', 'phone': '33 (0)3 88 12 73 20'}], 'facility': 'Service de Reanimation Pediatrique Specialisee - S. Continue', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne-Sophie Guilbert, MD', 'role': 'CONTACT', 'email': 'anne-sophie.guilbert@chru-strasbourg.fr', 'phone': '33 (0)3 88 12 73 20'}, {'name': 'Lucie PETITDEMANGE', 'role': 'CONTACT', 'email': 'lucie.petitdemange@chru-strasbourg.fr', 'phone': '33 (0)3 88 12 73 20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}