Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03205592
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in antral cross sectional area measured by ultrasonography after suctioning gastric volume', 'timeFrame': 'prior to and immediately after suctioning of gastric content volume through a gastric tube', 'description': 'Ultrasound measurement of antral area and qualitative assessment'}, {'measure': 'Change in antral area after administration of prokinetic drug', 'timeFrame': 'Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)', 'description': 'If aspirated gastric content volume was \\> 250 ml, only 250 ml will be reinjected into the stomach and a prokientic drug will be administered (current protocol in our units). Antral area will be measured prior to and 90 min after the start of the infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill Patients']}, 'referencesModule': {'references': [{'pmid': '31802485', 'type': 'DERIVED', 'citation': "Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4."}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients hospitalized in 3 critical care units (Groupement hospitalier Sud Lyon, Saint Etienne, Marseille)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since \\>48 h\n\nExclusion Criteria:\n\n* Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy'}, 'identificationModule': {'nctId': 'NCT03205592', 'acronym': 'GastrICU', 'briefTitle': 'Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'L16-174'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound examination of the antrum', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Lionel BOUVET, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lionel Bouvet', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}