HFNC During Awake Craniotomy - Impact on Patient Comfort
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
1 other identifier
interventional
20
1 country
1
Brief Summary
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. Results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedMarch 2, 2021
November 1, 2018
1.8 years
November 26, 2018
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient comfort using VAS (1-10)
Patient comfort during awake craniotomy
During surgical procedure, an average of 6 hours
Secondary Outcomes (3)
Gas exchange (blood gas analysis)
During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
Post-operative pulmonary atelectasis using Ultrasound evaluation
Up to 15 minutes before PACU discharge
Incidence of oxygen desaturation (number of events with SaO2 < 90%)
During surgical procedure, an average of 6 hours
Study Arms (2)
HFNC
EXPERIMENTALHFNC will be started at flow of 40 L/min and FiO2 of 40%.
Oxygen Mask
OTHERStandard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- adult patients undergoing elective awake craniotomy
You may not qualify if:
- ASA \> 4
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LHSC
London, Ontario, N6A 5A5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2018
First Posted
December 4, 2018
Study Start
May 1, 2019
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
March 2, 2021
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share