Pulmonary AtelectasisNCT03763461
HFNC During Awake Craniotomy - Impact on Patient Comfort
A study testing HFNC and Oxygen Mask in people with Pulmonary Atelectasis and Patient Comfort, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Atelectasis, Patient Comfort
- What is being tested?
- HFNC and Oxygen Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing elective awake craniotomy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Atelectasis, Patient Comfort
- Being tested
- HFNC, Oxygen Mask
- Keywords
- Awake Craniotomy, HFNC, Oxygen Therapy, Atelectasis, Ultrasound, Patient Comfort
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
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 MaskDevice
Application of oxygen during conscious sedation
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Experimental | HFNC will be started at flow of 40 L/min and FiO2 of 40%. Receives: Device: HFNC |
| Oxygen Mask | Other | Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed. Receives: Device: Oxygen Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort using VAS (1-10)
Patient comfort during awake craniotomy
Measured: During surgical procedure, an average of 6 hours
Secondary outcomes (3)
Gas exchange (blood gas analysis)
Measured: During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
Post-operative pulmonary atelectasis using Ultrasound evaluation
Measured: Up to 15 minutes before PACU discharge
Incidence of oxygen desaturation (number of events with SaO2 < 90%)
Measured: During surgical procedure, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 May 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763461
- Sponsor's protocol ID
- 112229
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03763461
- Acronym / sponsor ID
- 112229
- Conditions
- Pulmonary Atelectasis, Patient Comfort
- Keywords
- Awake Craniotomy, HFNC, Oxygen Therapy, Atelectasis, Ultrasound, Patient Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | Experimental | Device: HFNCHFNC will be started at flow of 40 L/min and FiO2 of 40%. |
| Oxygen Mask | Other | Device: Oxygen MaskStandard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing elective awake craniotomy
Key exclusion criteria (7 listed)
- ASA > 4
- pregnant females
- Body Mass Index (BMI) > 40
- elective postoperative mechanical ventilation/conversion to general anesthesia
- denial of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNCHigh 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. | Device | HFNC |
| Oxygen MaskApplication of oxygen during conscious sedation | Device | Oxygen Mask |
Primary outcome
Patient comfort using VAS (1-10)
Time frame: During surgical procedure, an average of 6 hours
Patient comfort during awake craniotomy
3 secondary outcomes
Gas exchange (blood gas analysis)
Time frame: During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
Post-operative pulmonary atelectasis using Ultrasound evaluation
Time frame: Up to 15 minutes before PACU discharge
Incidence of oxygen desaturation (number of events with SaO2 < 90%)
Time frame: During surgical procedure, an average of 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and Oxygen Mask in people with Pulmonary Atelectasis and Patient Comfort, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort using VAS (1-10) (time frame: During surgical procedure, an average of 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.