Clinical trial NCT03763461: HFNC During Awake Craniotomy - Impact on Patient Comfort
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Patient Comfort
Keywords: Awake Craniotomy
HFNC
Oxygen Therapy
Atelectasis
Ultrasound
Patient Comfort
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient comfort using VAS (1-10)
timeFrame: During surgical procedure, an average of 6 hours
Secondary outcomes:
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
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC
state: Ontario
Study officials:
References: