Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-16 @ 3:01 PM
Study NCT ID:
NCT04494802
Status:
UNKNOWN
Last Update Posted:
2020-08-04
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008150', 'term': 'Lower Body Negative Pressure'}], 'ancestors': [{'id': 'D003664', 'term': 'Decompression'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of gastric insufflation(antrum)', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound'}], 'secondaryOutcomes': [{'measure': 'The size of gastric antrum and body', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery'}, {'measure': 'Time for insertion of LMA flexible', 'timeFrame': 'During the anesthesia induction(up to 1 hour)', 'description': 'Time for insertion of LMA flexible'}, {'measure': 'Success rate of insertion of LMA flexible', 'timeFrame': 'During the anesthesia induction(up to 1 hour)', 'description': 'Success rate of insertion of LMA flexible'}, {'measure': 'The number of insertion attempt', 'timeFrame': 'During the anesthesia induction(up to 1 hour)', 'description': 'The number of insertion attempt'}, {'measure': 'The number and the type of additional manipulation for successful ventilation', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'The number and the type of additional manipulation for successful ventilation'}, {'measure': 'Ease of insertion of LMA flexible', 'timeFrame': 'During the anesthesia induction(up to 1 hour)', 'description': 'Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)'}, {'measure': 'Incidence of gastric insufflation(body)', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'Incidence of gastric insufflation which was recognized in gastric body with ultrasound'}, {'measure': 'Incidence of gastric insufflation recognized with the ausculation', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'Incidence of gastric insufflation recognized with the ausculation after finishing surgery'}, {'measure': 'peak pressure observed before, during, after surgery', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'peak pressure observed before, during, after surgery'}, {'measure': 'oropharyngeal leak pressure', 'timeFrame': 'During the surgery(up to 3 hours)', 'description': 'oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery'}, {'measure': 'the complication rate', 'timeFrame': 'During the surgery and after surgery (up to 6 hours)', 'description': 'the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aspiration']}, 'descriptionModule': {'briefSummary': 'Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients undergoing general anesthesia with LMA flexible\n\nExclusion Criteria:\n\n* Unstable vital sign, significant arrhythmia or hypotension, Shock\n* anticipated difficult intubation or the patient who have facial deformity\n* high risk of aspiration\n* recent upper respiratory tract infection history'}, 'identificationModule': {'nctId': 'NCT04494802', 'briefTitle': 'The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients', 'orgStudyIdInfo': {'id': 'Gastric insufflation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'higher pressure', 'description': 'During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O', 'interventionNames': ['Behavioral: higher pressure']}, {'type': 'EXPERIMENTAL', 'label': 'lower pressure', 'description': 'During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O', 'interventionNames': ['Behavioral: lower pressure']}], 'interventions': [{'name': 'lower pressure', 'type': 'BEHAVIORAL', 'description': 'During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O', 'armGroupLabels': ['lower pressure']}, {'name': 'higher pressure', 'type': 'BEHAVIORAL', 'description': 'During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O', 'armGroupLabels': ['higher pressure']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin-Tae Kim, PhD', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '82-2-2072-3664'}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}