Apneic OxygenationNCT03195504
High-flow Nasal Oxygenation in Obese Patients During Apnea
A study testing HFNC in people with Apneic Oxygenation and High-flow Nasal Cannulae, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apneic Oxygenation, High-flow Nasal Cannulae, Bariatric Surgery
- What is being tested?
- HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2017to 1 Apr 2018
- 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
- Age more than18 years old
- ASA status I-III
- Elective surgery performed under general anesthesia requiring endotracheal intubation
- BMI more than 40 kg/m2
Who cannot join
- Chronic respiratory disease
- SpO2 <98% after supplementing oxygen
- Previous or anticipated difficult intubation
- Uncontrolled hypertension
- Ischemic heart disease
- Congestive heart failure
Show all 10Show fewer
- Increased intracranial pressure
- Uncontrolled GERD
- Known allergy or contraindication to anesthesia drugs
- Nasal blockade contraindicating the use of HFNC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.
- Being tested
- HFNC, CON (control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
High flow nasal oxygen (60 l) under GA
CON (control)Device
Standard oxygen (10-15 l) under GA
| Study group | Role | What they receive |
|---|---|---|
| HFNC (High Flow Nasal Cannulae) | Experimental | High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia Receives: Device: HFNC |
| CON (control) | Active comparator | Standard flow oxygen during induction of anesthesia Receives: Device: CON (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of safe apnea time
Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes
Measured: Maximum up to 6 minutes
Secondary outcomes (3)
Highest EtCO2
Highest EtCO2 on commencing ventilation
Measured: Every minute up to 5 minutes on commencing ventilation
Lowest SpO2
Lowest SpO2 during intubation procedure
Measured: Every minute up to 5 minutes after intubation
Time to regain baseline SpO2
Time to regain baseline SpO2 after intubation
Measured: Up to 5 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start10 Aug 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Parallel groups
- Model description
- Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Wong, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195504
- Sponsor's protocol ID
- 16-6264.0
- Status last verified
- Apr 2019
- First submitted
- 5 Jun 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.
PubMed 31584919
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03195504
- Acronym / sponsor ID
- 16-6264.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 22 Jun 2017 (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.
Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.
| Arm | Type | Receives |
|---|---|---|
| HFNC (High Flow Nasal Cannulae) | Experimental | Device: HFNCHigh Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia |
| CON (control) | Active comparator | Device: CON (control)Standard flow oxygen during induction of anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than18 years old
- ASA status I-III
- Elective surgery performed under general anesthesia requiring endotracheal intubation
- BMI more than 40 kg/m2
Key exclusion criteria (10 listed)
- Chronic respiratory disease
- SpO2 <98% after supplementing oxygen
- Previous or anticipated difficult intubation
- Uncontrolled hypertension
- Ischemic heart disease
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 oxygen (60 l) under GA | Device | HFNC (High Flow Nasal Cannulae) |
| CON (control)Standard oxygen (10-15 l) under GA | Device | CON (control) |
Primary outcome
Measurement of safe apnea time
Time frame: Maximum up to 6 minutes
Safe apnea time, defined by time to desaturation (SpO2 > 95%) or apnea maximum up to 6 minutes
3 secondary outcomes
Highest EtCO2
Time frame: Every minute up to 5 minutes on commencing ventilation
Lowest SpO2
Time frame: Every minute up to 5 minutes after intubation
Time to regain baseline SpO2
Time frame: Up to 5 minutes after intubation
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 19 Apr 2019.
- Derived from this study: PubMed 31584919Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.
- Individual participant dataSharing planned: Undecided
Related trials for Apneic Oxygenation
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Oxygen Reserve Index (ORi) in Identifying Desaturation
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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 in people with Apneic Oxygenation and High-flow Nasal Cannulae, run by University Health Network, Toronto 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 4 inclusion and 10 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 19 Apr 2019. 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?
Measurement of safe apnea time (time frame: Maximum up to 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195504, which also lists 1 linked publication.
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 19 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.