Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 9:38 PM
Study NCT ID:
NCT04979533
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2021-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Insufflation in Microlaryngoscopies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'There will be a single group of participants in which all receive oxygen insufflation to see if oxygen insufflation is adequate in microlaryngoscopy airway surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Professional decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures', 'timeFrame': '30-60 minutes', 'description': '15 liters per minute of oxygen will be administered to the posterior oropharynx.'}], 'secondaryOutcomes': [{'measure': 'Degree of hypercapnia experienced by participants', 'timeFrame': '30-60 minutes', 'description': 'Measurement will be taken by intermittent ventilation by placing an endotracheal tube'}, {'measure': 'Participants That Maintain Adequate Oxygenation at 90% or Greater', 'timeFrame': '30-60 minutes', 'description': 'Pulse oximetry will be used to measure oxygenation status'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['surgery', 'airway', 'hypoxia prevention', 'oxygen insufflation'], 'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \\[finger device used in medicine\\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.', 'detailedDescription': "High flow, low pressure oxygen will be supplied in microlaryngoscopy airway surgery. These procedures are usually performed with jet ventilation (UAB) or intermittent apnea (surgery centers). Jet ventilation provides oxygenation with limited ventilation but come with high risks, such as barotrauma, pneumothorax, mucosa drying, and even death in the most severe cases. Intermittent apnea is a nuisance for the surgeon in that surgical time is often interrupted with having to place the endotracheal tube whenever the patient's oxygen saturation levels fall. The solution is oxygen insufflation, which will give extended oxygenation times for the surgeon to operate without the inherent risks associated with jet ventilation. During the procedure, oxygen tubing will be connected to the surgeon's laryngoscope instead of the jet ventilation tubing. Oxygen flows of 15 L/min will be administered through the laryngoscope to the posterior oropharynx. Endotracheal tube will be placed if oxygenation deemed insufficient due to oxygen saturations of \\<90%. Endotracheal tube will be intermittently placed to check and correct carbon dioxide levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing microlaryngoscopy surgery without a tracheostomy\n\nExclusion Criteria:\n\n* patients who have a tracheostomy'}, 'identificationModule': {'nctId': 'NCT04979533', 'briefTitle': 'Oxygen Insufflation in Microlaryngoscopies', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases', 'orgStudyIdInfo': {'id': 'IRB-300007262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxygen Insufflation', 'description': 'Oxygen insufflation via oxygen tubing at 15 L/min', 'interventionNames': ['Device: Insufflator oxygen tubing']}], 'interventions': [{'name': 'Insufflator oxygen tubing', 'type': 'DEVICE', 'otherNames': ['Flexible Oxygen tubing'], 'description': "high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.", 'armGroupLabels': ['Oxygen Insufflation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hollie N Sanders, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The oxygen saturation numbers throughout each surgery will be recorded with no personal identifying data of each patient.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Certified Registered Nurse Anesthetist', 'investigatorFullName': 'Hollie Sanders', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}