Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 9:08 AM
Study NCT ID:
NCT03763461
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2018-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFNC During Awake Craniotomy - Impact on Patient Comfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient comfort using VAS (1-10)', 'timeFrame': 'During surgical procedure, an average of 6 hours', 'description': 'Patient comfort during awake craniotomy'}], 'secondaryOutcomes': [{'measure': 'Gas exchange (blood gas analysis)', 'timeFrame': 'During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission'}, {'measure': 'Post-operative pulmonary atelectasis using Ultrasound evaluation', 'timeFrame': 'Up to 15 minutes before PACU discharge'}, {'measure': 'Incidence of oxygen desaturation (number of events with SaO2 < 90%)', 'timeFrame': 'During surgical procedure, an average of 6 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Awake Craniotomy', 'HFNC', 'Oxygen Therapy', 'Atelectasis', 'Ultrasound', 'Patient Comfort'], 'conditions': ['Pulmonary Atelectasis', 'Patient Comfort']}, 'descriptionModule': {'briefSummary': 'Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.\n\nResults of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.', 'detailedDescription': 'Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively.\n\nHypothesis: Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.\n\nMethods: After obtaining ethics approval and written informed patient consent, 20 patients undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be performed during and after the procedure. Lung ultrasound will be performed in the recovery room to determine the presence of atelectasis.\n\nExpected results and Significance: We expect that HFNC improves patient comfort as well as breathing / arterial oxygen content in long-duration awake brain surgery. This could result in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide - which could lead to better surgical conditions due to softer brain tissue and therefore shorter time for the surgical procedure. Potential positive results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing elective awake craniotomy\n\nExclusion Criteria:\n\n* ASA \\> 4\n* pregnant females\n* Body Mass Index (BMI) \\> 40\n* elective postoperative mechanical ventilation/conversion to general anesthesia\n* denial of consent\n* obstructive sleep apnea requiring CPAP\n* severe COPD requiring home oxygen therapy'}, 'identificationModule': {'nctId': 'NCT03763461', 'briefTitle': 'HFNC During Awake Craniotomy - Impact on Patient Comfort', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Comparison of Pre-warmed, Humidified High Flow Nasal Cannula (HFNC) Oxygen Therapy and Traditional Oxygen Therapy on Patient Comfort and Gas Exchange During Awake Craniotomy - A Single Centre, Prospective, Randomized, Pilot Trial', 'orgStudyIdInfo': {'id': '112229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNC', 'description': 'HFNC will be started at flow of 40 L/min and FiO2 of 40%.', 'interventionNames': ['Device: HFNC']}, {'type': 'OTHER', 'label': 'Oxygen Mask', 'description': 'Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.', 'interventionNames': ['Device: Oxygen Mask']}], 'interventions': [{'name': 'HFNC', 'type': 'DEVICE', 'description': 'High flow nasal humidified oxygen HFNC is an air-oxygen blender, which provides high flow (up to 60 L/min) of warmed (36°C) and humidified gas through nasal cannula, allowing tighter control of FiO2 from 0.2 to 1.0.', 'armGroupLabels': ['HFNC']}, {'name': 'Oxygen Mask', 'type': 'DEVICE', 'description': 'Application of oxygen during conscious sedation', 'armGroupLabels': ['Oxygen Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LHSC', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}