HFNC During Awake Craniotomy - Impact on Patient Comfort

Pulmonary Atelectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763461
• Other study ID #: 112229
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: November 2018
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Comfort
• Pulmonary Atelectasis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	LHSC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort using VAS (1-10)	Patient comfort during awake craniotomy	During surgical procedure, an average of 6 hours
Secondary	Gas exchange (blood gas analysis)		During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
Secondary	Post-operative pulmonary atelectasis using Ultrasound evaluation		Up to 15 minutes before PACU discharge
Secondary	Incidence of oxygen desaturation (number of events with SaO2 < 90%)		During surgical procedure, an average of 6 hours