PreoxygenationPOPNCT03310723
Pre-Oxygenation Techniques in Pregnancy
A study testing Face Mask preoxygenation and OptiFlow preoxygenation in people with Preoxygenation, run by University of British Columbia at 1 site in Canada.
Trial summary
A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Face Mask preoxygenation and OptiFlow preoxygenation
- 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 Nov 2017to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (American Society of Anesthesiologists class 1 or 2), pregnant patients ≥36 weeks gestation scheduled for elective Cesarean delivery under neuraxial anesthesia.
Who cannot join
- Comorbidities likely to alter outcome of respiration and gas exchange.
- Patients only able to breathe through their mouth.
- Patients who are in active labour.
- Patients unable to tolerate a face mask being held over their mouth and nose.
- Patients with a Body Mass Index ≥40kg/m2.
- Patients who are unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial
A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.
Read the detailed description
Pre-oxygenation is performed prior to general anesthesia to prevent hypoxia during airway management. It is typically performed using a standard tight-fitting face mask; however, recent advances in oxygenation have occurred through the use of trans-nasal oxygen delivery devices, such as OptiFlow. There is limited evidence of the use of OptiFlow in the pregnant patient, and as such, this study aims to show that OptiFlow is as effective at pre-oxygenation as a standard tight-fitting face-mask technique in the pregnant population.
- Conditions
- Preoxygenation
- Being tested
- Face Mask preoxygenation, OptiFlow preoxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face Mask preoxygenationDevice
Standard face mask preoxygenation.
OptiFlow preoxygenationDevice
Also called THRIVE
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
| Study group | Role | What they receive |
|---|---|---|
| Standard Face Mask Preoxygenation | Active comparator | Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min. Receives: Device: Face Mask preoxygenation |
| Optiflow Preoxygenation | Experimental | Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. Receives: Device: OptiFlow preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow
Measured: From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing
Secondary outcomes (1)
End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow
Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow
Measured: From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start10 Nov 2017
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD MMSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310723
- Sponsor's protocol ID
- H17-01996
- Acronym
- POP
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2017
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03310723
- Acronym / sponsor ID
- POP / H17-01996
- Conditions
- Preoxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.
Detailed description
Pre-oxygenation is performed prior to general anesthesia to prevent hypoxia during airway management. It is typically performed using a standard tight-fitting face mask; however, recent advances in oxygenation have occurred through the use of trans-nasal oxygen delivery devices, such as OptiFlow. There is limited evidence of the use of OptiFlow in the pregnant patient, and as such, this study aims to show that OptiFlow is as effective at pre-oxygenation as a standard tight-fitting face-mask technique in the pregnant population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Face Mask Preoxygenation | Active comparator | Device: Face Mask preoxygenationTidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min. |
| Optiflow Preoxygenation | Experimental | Device: OptiFlow preoxygenationTidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy (American Society of Anesthesiologists class 1 or 2), pregnant patients ≥36 weeks gestation scheduled for elective Cesarean delivery under neuraxial anesthesia.
Key exclusion criteria (6 listed)
- Comorbidities likely to alter outcome of respiration and gas exchange.
- Patients only able to breathe through their mouth.
- Patients who are in active labour.
- Patients unable to tolerate a face mask being held over their mouth and nose.
- Patients with a Body Mass Index ≥40kg/m2.
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 |
|---|---|---|
| Face Mask preoxygenationStandard face mask preoxygenation. | Device | Standard Face Mask Preoxygenation |
| OptiFlow preoxygenationAlso: THRIVEPreoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). | Device | Optiflow Preoxygenation |
Primary outcome
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
Time frame: From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing
Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow
1 secondary outcome
End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow
Time frame: From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Preoxygenation
Not yet recruitingObservational study
Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
Sarcopenia, Handgrip Strength Test
Recruiting
Physiological Effects of Different Preoxygenation Strategies
Preoxygenation
Active, not recruiting
Verbal Breathing Coaching to Improve Preoxygenation and Extend Safe Apnea Time in Anesthesia
Preoxygenation
Active, not recruiting
Comparison of Different Oxygen Flow Rates During Preoxygenation Using High-Flow Nasal Oxygen
Airway Anesthesia, Preoxygenation
Not yet recruitingObservational study
Comparison of the Time to Reach End-Tidal Oxygen Value of 90 and Oxygen Reserve Index Decline Times During Preoxygenation in Sarcopenic and Non-Sarcopenic Patients
Sarcopenia, Preoxygenation
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.
Anton Chau, MD MMSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face Mask preoxygenation and OptiFlow preoxygenation in people with Preoxygenation, run by University of British Columbia 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 6 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 16 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow (time frame: From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing). 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 16 Sep 2020; AzTrials last refreshed its copy on 27 Oct 2026.