Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT02906267
Status:
UNKNOWN
Last Update Posted:
2017-07-17
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-13', 'studyFirstSubmitDate': '2016-09-05', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric volume before and after positive pressure ventilation', 'timeFrame': '15 minutes'}], 'secondaryOutcomes': [{'measure': 'Ultrasonographic detection of gastric insufflation during ventilation', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Positive-Pressure Respiration', 'Respiratory Aspiration of Gastric Content']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)', 'detailedDescription': 'Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (\\<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I and II\n\nExclusion Criteria:\n\n* Pregnant woman Obese patient (BMI\\>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal'}, 'identificationModule': {'nctId': 'NCT02906267', 'acronym': 'UGV', 'briefTitle': 'Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'Ultrasonic gastric volume'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Manual-controlled', 'description': 'Patient in the manual ventilation group will receive facemask ventilation to get a tidal volume of 8-10ml/kg with a respiratory rate of 15/min. The pop-off valve will be set to 20 cm H2O.', 'interventionNames': ['Other: Diagnostic ultrasonography of gastric volume']}, {'type': 'OTHER', 'label': 'Volume-controlled', 'description': 'mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Tidal volume will be set to 8-10 ml/min.', 'interventionNames': ['Other: Diagnostic ultrasonography of gastric volume']}, {'type': 'OTHER', 'label': 'Pressure-controlled', 'description': 'mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Pressure will be adjusted to obtain a tidal volume of 8-10 ml/min.', 'interventionNames': ['Other: Diagnostic ultrasonography of gastric volume']}], 'interventions': [{'name': 'Diagnostic ultrasonography of gastric volume', 'type': 'OTHER', 'description': 'Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)', 'armGroupLabels': ['Manual-controlled', 'Pressure-controlled', 'Volume-controlled']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre LAFERE, MD, PhD', 'role': 'CONTACT', 'email': 'pierre.lafere@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Pierre LAFERE, MD, PhD', 'role': 'CONTACT', 'email': 'pierre.lafere@chu-brest.fr', 'phone': '0033298347658'}], 'overallOfficials': [{'name': 'Pierre LAFERE, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docteur Pierre Lafère', 'investigatorFullName': 'LAFERE Pierre', 'investigatorAffiliation': 'University Hospital, Brest'}}}}