Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 8:24 PM
Study NCT ID:
NCT04238351
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transnasal Humidified Rapid Insufflation System for Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, care giver and outcome assessor can not know the group assingment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Applying Transnasal humidified rapid insufflation ventilator exchange'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desaturation', 'timeFrame': 'during the anesthesia induciton', 'description': 'number of patients who experienced SpO2 under 93%'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia']}, 'descriptionModule': {'briefSummary': 'Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction', 'detailedDescription': 'Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who scheduled for elective lung surery with one lung ventilation\n\nExclusion Criteria:\n\n* suspicious difficult intubation (BMI \\>35kg/m2, mouth opening \\< 3 finger, Mallampati G \\>3), Room air SpO2 \\< 90%, active pulmonary infection, emergency operation, pregnancy'}, 'identificationModule': {'nctId': 'NCT04238351', 'briefTitle': 'Transnasal Humidified Rapid Insufflation System for Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube', 'orgStudyIdInfo': {'id': 'Gil2019-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'usual mask ventilation during anethesia induction', 'interventionNames': ['Device: Conventional face mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THRIVE', 'description': 'Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction', 'interventionNames': ['Device: Transnasal humidified rapid insufflation ventilator exchange']}], 'interventions': [{'name': 'Transnasal humidified rapid insufflation ventilator exchange', 'type': 'DEVICE', 'description': 'applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.', 'armGroupLabels': ['THRIVE']}, {'name': 'Conventional face mask', 'type': 'DEVICE', 'description': 'applying oxygen using usual face mask', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Youn Yi Jo', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}