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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03763461
Enrollment
20
Registered
2018-12-04
Start date
2019-05-01
Completion date
2021-02-28
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Atelectasis, Patient Comfort

Keywords

Awake Craniotomy, HFNC, Oxygen Therapy, Atelectasis, Ultrasound, Patient Comfort

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.

Detailed description

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. 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.

Interventions

DEVICEHFNC

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.

Application of oxygen during conscious sedation

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients undergoing elective awake craniotomy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient comfort using VAS (1-10)During surgical procedure, an average of 6 hoursPatient comfort during awake craniotomy

Secondary

MeasureTime frame
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 evaluationUp to 15 minutes before PACU discharge
Incidence of oxygen desaturation (number of events with SaO2 < 90%)During surgical procedure, an average of 6 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026