Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT06664294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between ultrasonography and clinical tests', 'timeFrame': '24 hours', 'description': 'Our primary aim was investigation of correlation between ultrasonography and clinical tests for placement of supraglottic airway device in pediatric patients.'}], 'secondaryOutcomes': [{'measure': 'mesuring airway pressures', 'timeFrame': '24 hours', 'description': 'Our secondary aim was measuring airway pressures, measuring the difference between the tidal volume delivered from the anesthesia device and the volume withdrawn from the patient, and its correlation with correct placement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['supraglottic airway pediatric airway,airway ultrasound'], 'conditions': ['Airway Ultrasound']}, 'referencesModule': {'references': [{'pmid': '25545750', 'type': 'BACKGROUND', 'citation': 'Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551.'}]}, 'descriptionModule': {'briefSummary': 'In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging.', 'detailedDescription': 'After informing the patients about the study and possible risks, written consent was obtained from all patients. After routine anesthesia technique was applied to the patients, supraglottic airway device was inserted. The placement of the airway device was evaluated with ultrasonography. Airway pressures reflected on the anesthesia device were recorded. The correlation between airway pressures and ultrasonographic images was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients aged 3-15 years with an operation time of less than 2 hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with informed consent from their parents\n* Patients with ASA I-II physical status\n* Patients with appropriate fasting time\n* Those with an operation time of less than 2 hours\n\nExclusion Criteria:\n\n* ASA III-IV physical status patients\n* Patients with respiratory tract infections\n* Patients undergoing head and neck surgery\n* Patients with oropharyngeal pathology\n* Patients with gastrointestinal obstruction\n* Patients with tracheomalacia\n* Patients who need to be intubated for anesthesia applications'}, 'identificationModule': {'nctId': 'NCT06664294', 'briefTitle': 'The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS', 'orgStudyIdInfo': {'id': 'KAEK2024/171'}}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'İzmit', 'state': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 40.76499, 'lon': 29.92928}}], 'overallOfficials': [{'name': 'can aksu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Çalışmanın kopyalanmasının önüne geçmek için'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Busra Yaka', 'investigatorAffiliation': 'Kocaeli University'}}}}