Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT03432403
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2018-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excessive intracuff pressure', 'timeFrame': 'as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes', 'description': 'Our primary goal is to compare the incidence of excessive intracuff pressure after EGD probe insertion between the newly designed LMA and the older version LMA. For this primary outcome, we will define excessive intracuff pressure as ≥40 cmH2O.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracuff Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this current study is to compare changes of the intracuff pressure in the newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy (EGD) probe in pediatric patients and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who weigh more than 30 kg who are undergoing an EGD and who are getting an LMA at Nationwide Children's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who weigh more than 30 kg\n* Patients undergoing an EGD\n* Patients getting an LMA\n\nExclusion Criteria:\n\n* Patients who weigh less than 30 kg\n* Use of an EGD probe with an OD greater than 14 mm\n* Decision not to use an LMA for the procedure\n* Tracheomalacia, bronchomalacia, or any other airway issues'}, 'identificationModule': {'nctId': 'NCT03432403', 'briefTitle': 'The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children', 'orgStudyIdInfo': {'id': 'IRB17-00680'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New LMA or Old LMA', 'description': 'newly designed LMA or older designed LMA', 'interventionNames': ['Device: Ambu LMA', 'Device: Gastro LMA']}], 'interventions': [{'name': 'Ambu LMA', 'type': 'DEVICE', 'otherNames': ['old LMA'], 'description': 'Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured', 'armGroupLabels': ['New LMA or Old LMA']}, {'name': 'Gastro LMA', 'type': 'DEVICE', 'otherNames': ['new LMA'], 'description': 'Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured', 'armGroupLabels': ['New LMA or Old LMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Bryant', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jason Bryant', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}