Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-13 @ 4:17 AM
Study NCT ID:
NCT02441257
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2015-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2015-01-25', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of gastroesophageal reflux of participants', 'timeFrame': 'participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours', 'description': 'evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux', 'Laryngeal Mask Airway', 'Control Ventilation', 'Spontaneous Ventilation'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'Laryngeal mask airway is seldom used for control ventilation in America, while it is popular in China. The question is whether the incidence of gastroesophageal reflux in control ventilation is really higher than in spontaneous ventilation. So the investigators combine the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to evaluate the exact incidence of gastroesophageal reflux in these two groups.', 'detailedDescription': 'Patients scheduled for LMA ventilation are divided into two groups randomly, control ventilation group and spontaneous ventilation group. After the third generation laryngeal mask is inserted, catheter-based Digitrapper ph-Z monitor system is applied to measure the exact incidence of gastroesophageal reflux in these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients for lower extremity operations;\n* patients for urological operations;\n* patients for gynecological operations.\n\nExclusion Criteria:\n\n* gastroesophageal reflux disease;\n* body mass index more than 30.'}, 'identificationModule': {'nctId': 'NCT02441257', 'acronym': 'LMA', 'briefTitle': 'Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation', 'orgStudyIdInfo': {'id': 'EHBH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control ventilation', 'description': 'patients are scheduled to receive control or spontaneous ventilation', 'interventionNames': ['Procedure: control ventilation', 'Procedure: spontaneous ventilation']}], 'interventions': [{'name': 'control ventilation', 'type': 'PROCEDURE', 'description': 'patients are randomly divided to receive control or spontaneous ventilation randomly.', 'armGroupLabels': ['control ventilation']}, {'name': 'spontaneous ventilation', 'type': 'PROCEDURE', 'description': 'patients are randomly divided to receive control or spontaneous ventilation randomly.', 'armGroupLabels': ['control ventilation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhenmeng Wang, Doctor', 'role': 'CONTACT', 'email': 'wzm11998@163.com', 'phone': '+8613601919501'}], 'overallOfficials': [{'name': 'Zhenmeng Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhenmeng Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Zhenmeng Wang', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}}