Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT03222869
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure (cm H20)', 'timeFrame': 'Up to One Year', 'description': 'Using a pressure gauge to measure pressure at locations in the airway'}], 'secondaryOutcomes': [{'measure': 'Flow Rate (L/min)', 'timeFrame': 'Up to One Year', 'description': 'using a flow sensor to measure low rate at locations in airway'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngotracheal Stenosis']}, 'descriptionModule': {'briefSummary': 'This research is being done to determine the resistance across stenosis in the airway.', 'detailedDescription': 'There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.\n\nExclusion Criteria:\n\n* Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)\n* Patients that are not cleared for surgery by the preoperative evaluation\n* Patients with severe laryngotracheal stenosis\n* Patients who are morbidly obese (BMI \\> 40)\n* Patients with lung disease (asthma, COPD)'}, 'identificationModule': {'nctId': 'NCT03222869', 'briefTitle': 'Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery', 'orgStudyIdInfo': {'id': 'IRB00096150'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laryngotracheal Stenosis', 'description': 'Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured', 'interventionNames': ['Diagnostic Test: Measure Airway Resistance Across Stenosis']}], 'interventions': [{'name': 'Measure Airway Resistance Across Stenosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measure pressure and air flow Across Stenosis', 'armGroupLabels': ['Laryngotracheal Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Alexander Hillel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}