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HFNC During Awake Craniotomy - Impact on Patient Comfort

Primary Purpose

Pulmonary Atelectasis, Patient Comfort

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HFNC
Oxygen Mask
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Awake Craniotomy, HFNC, Oxygen Therapy, Atelectasis, Ultrasound, Patient Comfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • LHSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HFNC

Oxygen Mask

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient comfort using VAS (1-10)
Patient comfort during awake craniotomy

Secondary Outcome Measures

Gas exchange (blood gas analysis)
Post-operative pulmonary atelectasis using Ultrasound evaluation
Incidence of oxygen desaturation (number of events with SaO2 < 90%)

Full Information

First Posted
November 26, 2018
Last Updated
March 1, 2021
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03763461
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Patient Comfort
Keywords
Awake Craniotomy, HFNC, Oxygen Therapy, Atelectasis, Ultrasound, Patient Comfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC
Arm Type
Experimental
Arm Description
HFNC will be started at flow of 40 L/min and FiO2 of 40%.
Arm Title
Oxygen Mask
Arm Type
Other
Arm Description
Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oxygen Mask
Intervention Description
Application of oxygen during conscious sedation
Primary Outcome Measure Information:
Title
Patient comfort using VAS (1-10)
Description
Patient comfort during awake craniotomy
Time Frame
During surgical procedure, an average of 6 hours
Secondary Outcome Measure Information:
Title
Gas exchange (blood gas analysis)
Time Frame
During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
Title
Post-operative pulmonary atelectasis using Ultrasound evaluation
Time Frame
Up to 15 minutes before PACU discharge
Title
Incidence of oxygen desaturation (number of events with SaO2 < 90%)
Time Frame
During surgical procedure, an average of 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
LHSC
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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HFNC During Awake Craniotomy - Impact on Patient Comfort

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