HFNC During Awake Craniotomy - Impact on Patient Comfort

Western University, Canada

Status: Completed

Conditions: Patient Comfort; Pulmonary Atelectasis

Treatments: Device: Oxygen Mask; Device: HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT03763461

112229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

HFNC

Experimental group

Description:

HFNC will be started at flow of 40 L/min and FiO2 of 40%.

Treatment:

Device: HFNC

Oxygen Mask

Other group

Description:

Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.

Treatment:

Device: Oxygen Mask