Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-09 @ 6:30 AM
Study NCT ID:
NCT03905733
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005547', 'term': 'Foreign Bodies'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014135', 'term': 'Tracheal Stenosis'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxia occurs the first time', 'timeFrame': 'The time taken to reach the point at which peripheral oxygen saturation fell below 90% for the first time immediately after the onset of apnea intraoperatively.', 'description': 'The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea'}, {'measure': 'the lowest oxygen saturation', 'timeFrame': 'apnea period during the rigidbroscopic procedure/surgery', 'description': 'the lowest value of oxygen saturation measured percutaneously at extremity.'}, {'measure': 'Occurence of hypoxic event', 'timeFrame': 'apnea period during the rigidbroscopic procedure/surgery', 'description': 'Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy'}], 'secondaryOutcomes': [{'measure': 'End-tidal carbon dioxide partial pressure', 'timeFrame': 'end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea during intraoperative period.'}, {'measure': 'Arterial oxygen / carbon dioxide partial pressure', 'timeFrame': 'shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foreign Bodies', 'Tumor', 'Stenosis of Trachea', 'Bronchus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on maintenance of oxygenation and removal of carbon dioxide during apnoeic period in pediatric patients undergoing general anesthesia with rigid bronchoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope\n* 2\\. Patients aged 7 or younger who meet American Society of Anesthesiologists (ASA) physical class 2-4\n\nExclusion Criteria:\n\n* 1\\. Patients undergoing extracorporeal membrane oxygenation (ECMO)\n* 2\\. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery\n* 3\\. Patients with current maxillofacial trauma or basal skull fracture\n* 4\\. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery\n* 5\\. Extremely low birth weight infant and premature infant less than 28 weeks gestation age\n* 6\\. Patients who had previously undergone rigid bronchoscopy / surgery\n* 7\\. If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)'}, 'identificationModule': {'nctId': 'NCT03905733', 'briefTitle': 'The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients: A Prospective Observational Pilot Study', 'orgStudyIdInfo': {'id': '1-2019-0009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'general anesthesia with rigid bronchoscopy', 'description': 'Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy', 'interventionNames': ['Device: Optiflow']}], 'interventions': [{'name': 'Optiflow', 'type': 'DEVICE', 'description': 'supply of oxygen at 2 L / min/ kg through Optiflow', 'armGroupLabels': ['general anesthesia with rigid bronchoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang Young Lee, MD', 'role': 'CONTACT', 'email': 'CYLEECS@yuhs.ac', 'phone': '82-10-2720-7399'}], 'facility': 'Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}