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Completed

NCT Number: NCT03763461

HFNC During Awake Craniotomy - Impact on Patient Comfort

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.

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Key information

Conditions

Pulmonary Atelectasis Lung Diseases Patient Comfort Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHSC

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Oxygen Mask

Device

Application of oxygen during conscious sedation

Primary outcomes

  1. Patient comfort using VAS (1-10)

    Time frame: During surgical procedure, an average of 6 hours

    Patient comfort during awake craniotomy

Secondary outcomes

  1. Gas exchange (blood gas analysis)

    Time frame: During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission

  2. Post-operative pulmonary atelectasis using Ultrasound evaluation

    Time frame: Up to 15 minutes before PACU discharge

  3. Incidence of oxygen desaturation (number of events with SaO2 < 90%)

    Time frame: During surgical procedure, an average of 6 hours

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2018
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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