Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-05 @ 12:37 AM
Study NCT ID:
NCT02227134
Status:
WITHDRAWN
Last Update Posted:
2020-07-10
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to perform the ultrasound.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-08-26', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyo-mental distance', 'timeFrame': 'intraoperative', 'description': 'The distance from the hyoid bone to the mentum to predict difficult airway.'}], 'secondaryOutcomes': [{'measure': 'Tongue width', 'timeFrame': 'intraoperative', 'description': 'Width of the tongue between the lingual arteries.'}, {'measure': 'Tonsil Size', 'timeFrame': 'intraoperative', 'description': 'Size of tonsil (bilateral)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Difficult Airway', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.\n* Children with difficult tracheal intubation aged 1 month - 18 years old\n* Children with obstructive sleep apnea aged 1 year - 8 years old\n\nExclusion Criteria:\n\n* Parent/ patient refusal to participate in study'}, 'identificationModule': {'nctId': 'NCT02227134', 'briefTitle': 'Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB14-00572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Difficult Airway', 'description': 'Children with a history of difficult airway intubation.', 'interventionNames': ['Procedure: Ultrasound']}, {'type': 'OTHER', 'label': 'Obstructive Sleep Apnea', 'description': 'Children with a history of obstructive sleep apnea.', 'interventionNames': ['Procedure: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.', 'armGroupLabels': ['Difficult Airway', 'Obstructive Sleep Apnea']}]}, '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': 'Vidya Raman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Vidya Raman', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}