Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT03881033
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of atelectasis', 'timeFrame': '1min after ventilator-on', 'description': 'After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.'}], 'secondaryOutcomes': [{'measure': 'The incidence of gastric insufflation', 'timeFrame': 'During face mask ventilation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator Lung', 'Ultrasound']}, 'descriptionModule': {'briefSummary': 'The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.\n\nThe aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The ASA class I,II and 1-5 years pediatric patients need general anesthesia\n\nExclusion Criteria:\n\n* Oropharyngeal or facial pathology accompanied\n* Obese (BMI \\> 30 kg/m2)\n* GI tract obstruction'}, 'identificationModule': {'nctId': 'NCT03881033', 'briefTitle': 'Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-18-192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'P12', 'interventionNames': ['Other: Peak inspiratory pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P7+5', 'interventionNames': ['Other: Peep 5cmH2O']}], 'interventions': [{'name': 'Peep 5cmH2O', 'type': 'OTHER', 'otherNames': ['Peak inspiratory pressure'], 'description': 'Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.', 'armGroupLabels': ['P7+5']}, {'name': 'Peak inspiratory pressure', 'type': 'OTHER', 'description': 'Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.', 'armGroupLabels': ['P12']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Jiyoung Yoo', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}