Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT05181904
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation', 'timeFrame': '12 hours following the inclusion', 'description': 'Percentage of critically ill children presenting with a full stomach (according to PERLAS criteria) 6 hours after enteral feeding interruption for planned extubation. Gastric emptiness is assessed with gastric ultrasounding, depicting gastric content (empty versus full). Antral diameter will also be measured and gastric volume will be calculated to allow classifying gastric content according to PERLAS criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fasting', 'Extubation', 'Pediatric critical care', 'Gastric ultrasound', 'Aspiration'], 'conditions': ['Fasting', 'Pediatric ALL', 'Aspiration']}, 'descriptionModule': {'briefSummary': 'Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.\n\nWhen an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.\n\nGastric ultrasounding monitoring may help assessing gastric content prior to extubation.\n\nInvestigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 critically ill children (meeting inclusion criteria and respecting exclusion criteria), will be recruited in a single pediatric intensive care unit, if they are intubated and enterally fed on a gastric tube.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 17 year old children admitted to pediatric intensive care unit\n* intubated (oral or nasal tracheal tube)\n* gastric enteral feeding affording at least 25% of the nutritional target (estimated with Schofield equations)\n* No opposition from one of the 2 parents (or legal representatives)\n\nExclusion Criteria:\n\n* anatomical anomaly of the stomach location (e.g. post surgery)\n* Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)\n* mobilization to right lateral decubitus at risk'}, 'identificationModule': {'nctId': 'NCT05181904', 'acronym': 'GastrExtub', 'briefTitle': 'Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children', 'orgStudyIdInfo': {'id': '69HCL21_1249'}, 'secondaryIdInfos': [{'id': '2021-A03130-41', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill children ready for extubation', 'description': 'Children admitted to a paediatric intensive care unit, invasively ventilated and intubated, enterally fed and presenting with a clinical condition allowing for extubation. 45 children will be included.', 'interventionNames': ['Other: Gastric ultrasound']}], 'interventions': [{'name': 'Gastric ultrasound', 'type': 'OTHER', 'description': 'Assessment of gastric content with gastric ultrasound monitoring: gastric ultrasounds will be performed in eligible children, when enteral feeding is stopped for planned extubation, and repeated 6 hours after, at extubation and every hour between feeding interruption and extubation. The stomach will be classified as empty or full according to PERLAS criteria. In total, 8 gastric ultrasounds will be performed over a period of 12 hours.', 'armGroupLabels': ['Critically ill children ready for extubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric VALLA', 'role': 'CONTACT', 'email': 'Frederic.valla@chu-lyon.fr', 'phone': '04 72 12 97 35', 'phoneExt': '+33'}, {'name': 'Frédéric VALLA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Frédéric VALLA', 'role': 'CONTACT', 'email': 'Frederic.valla@chu-lyon.fr', 'phone': '04 72 12 97 35', 'phoneExt': '+33'}, {'name': 'Florent BAUDIN', 'role': 'CONTACT', 'email': 'Florent.baudin@chu-lyon.fr', 'phone': '04 72 12 97 35', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}