HFNC During Awake Craniotomy - Impact on Patient Comfort
NCT ID: NCT03763461
Last Updated: 2021-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-05-01
2021-02-28
Brief Summary
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Results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
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Detailed Description
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Hypothesis: 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.
Methods: 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.
Expected 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HFNC
HFNC will be started at flow of 40 L/min and FiO2 of 40%.
HFNC
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.
Oxygen Mask
Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.
Oxygen Mask
Application of oxygen during conscious sedation
Interventions
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HFNC
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.
Oxygen Mask
Application of oxygen during conscious sedation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnant females
* Body Mass Index (BMI) \> 40
* elective postoperative mechanical ventilation/conversion to general anesthesia
* denial of consent
* obstructive sleep apnea requiring CPAP
* severe COPD requiring home oxygen therapy
18 Years
ALL
No
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Locations
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LHSC
London, Ontario, Canada
Countries
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Other Identifiers
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112229
Identifier Type: -
Identifier Source: org_study_id
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