HFNC During Awake Craniotomy - Impact on Patient Comfort | NCT03763461

Studies
HFNC During Awake Craniotomy - Impact on Patient Comfort

NCT03763461

Sponsor

Western University, Canada

Status

Completed

Last Update Posted

Mar 2, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pulmonary Atelectasis
Patient Comfort

Interventions

HFNC
Oxygen Mask

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Nov 26, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HFNC	Experimental	HFNC will be started at flow of 40 L/min and FiO2 of 40%.	Device: HFNC
Oxygen Mask	Other	Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.	Device: Oxygen Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HFNC	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient comfort using VAS (1-10)	Patient comfort during awake craniotomy	During surgical procedure, an average of 6 hours

Secondary Outcomes

Measure	Description	Time 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 evaluation		Up to 15 minutes before PACU discharge

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LHSC		London	Ontario	N6A 5A5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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