PreoxygenationNCT03772574

Preoxygenation Using THRIVE Versus Facemask in Parturients

A study testing Facemask preoxygenation and THRIVE preoxygenation in people with Preoxygenation, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients. 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?: Facemask preoxygenation and THRIVE preoxygenation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteCanada
Study dates: 1 Dec 2018to 24 Apr 2020
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

Pregnant patients ≥36 weeks gestation.
Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
American Society of Anesthesiologists (ASA) class 2.

Who cannot join

Any medical conditions that are likely to affect gas exchange.
Obstructed nasal passage.
Unable to tolerate a tight fitting facemask.
Body Mass Index ≥40 kg/m2.
Patients who are in active labor (i.e. cervical dilation ≥4cm).
Patients who are unable to give informed consent.

Trial locations and contacts

1 site in 1 country.

Canada1 site

BC Women's Hospital
Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

Official title: Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

Read the detailed description

We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 >90%.

Conditions: Preoxygenation
Being tested: Facemask preoxygenation, THRIVE preoxygenation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Facemask preoxygenationDevice
Standard facemask preoxygenation
THRIVE preoxygenationDevice
Also called THRIVE
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Study groups in NCT03772574
Study group	Role	What they receive
THRIVE	Experimental	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Receives: Device: THRIVE preoxygenation
Facemask	Active comparator	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Receives: Device: Facemask preoxygenation

What is being measured

The primary outcome is the main question the study is designed to answer.

Preoxygenation Duration
Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
Measured: Maximum 8 minutes

Secondary outcomes (8)

Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
Measured: 3 minutes of pre-oxygenation
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
Measured: 4 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
Measured: 5 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
Measured: 6 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
Measured: 7 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
Measured: 8 minutes of preoxygenation
Comfort Score
Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)
Measured: 1 minute after data collection
Acceptability Score
Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
Measured: 1 minute after data collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201824 Apr 2020

First posted11 Dec 2018
Study start1 Dec 2018
Primary completion15 Jul 2019
Study completion24 Apr 2020

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.
Publications (1)Papers the sponsor has linked to this study.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03772574
Sponsor's protocol ID: H18-02855
Status last verified: May 2022
First submitted: 8 Dec 2018
Last updated: 24 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Au K, Shippam W, Taylor J, Albert A, Chau A. Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial. Anaesthesia. 2020 May;75(5):609-616. doi: 10.1111/anae.14995. Epub 2020 Feb 11.
PubMed 32048278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
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All Preoxygenation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients
ClinicalTrials.gov ID: NCT03772574
Acronym / sponsor ID: H18-02855
Conditions: Preoxygenation
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Study start: 1 Dec 2018 (actual)
Primary completion: 15 Jul 2019 (actual)
Study completion: 24 Apr 2020 (actual)
First posted: 11 Dec 2018 (actual)
Results: Posted 24 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

Detailed description

We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 >90%.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
THRIVE	Experimental	Device: THRIVE preoxygenationTHRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
Facemask	Active comparator	Device: Facemask preoxygenationFacemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Pregnant patients ≥36 weeks gestation.
Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
American Society of Anesthesiologists (ASA) class 2.

Key exclusion criteria (6 listed)

Any medical conditions that are likely to affect gas exchange.
Obstructed nasal passage.
Unable to tolerate a tight fitting facemask.
Body Mass Index ≥40 kg/m2.
Patients who are in active labor (i.e. cervical dilation ≥4cm).

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
Facemask preoxygenationStandard facemask preoxygenation	Device	Facemask
THRIVE preoxygenationAlso: THRIVEPreoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	Device	THRIVE

Primary outcome

Preoxygenation Duration
Time frame: Maximum 8 minutes
Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.

8 secondary outcomes

Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
Time frame: 3 minutes of pre-oxygenation
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
Time frame: 4 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
Time frame: 5 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
Time frame: 6 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
Time frame: 7 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
Time frame: 8 minutes of preoxygenation
Comfort Score
Time frame: 1 minute after data collection
Acceptability Score
Time frame: 1 minute after data collection

Results and safety

Results posted to the registry on 24 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Facemask	42	40
THRIVE	25	20
THRIVE and Facemask	24	20

Primary outcome: Preoxygenation Duration

Time frame: Maximum 8 minutes. Mean (95% Confidence Interval). Unit: minutes

Measure	Standard Facemask n = 40	THRIVE n = 20	THRIVE and Facemask n = 20
Value	3.6 (3.3 to 6.7)	NA (NA to NA)	NA (NA to NA)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Facemask	0 of 42 (0%)	0 of 42 (0%)	0 of 42
THRIVE	0 of 25 (0%)	0 of 25 (0%)	0 of 25
THRIVE and Facemask	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Limitations and caveats (from the sponsor): Our results are specific to healthy parturients using standard facemasks, or a high oxygen flow rate of 50L/min, and cannot be generalized to other techniques or populations. 9 parturients left the study due to discomfort, which may bias outcomes

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32048278Au K, Shippam W, Taylor J, Albert A, Chau A. Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial. Anaesthesia. 2020 May;75(5):609-616. doi: 10.1111/anae.14995. Epub 2020 Feb 11.
Individual participant dataSharing planned: No

Related trials for Preoxygenation

Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
Not yet recruitingObservational study
Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
Sarcopenia, Handgrip Strength Test
Not yet recruiting
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
Hypoxemia During Surgery
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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.

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 Facemask preoxygenation and THRIVE 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 3 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 24 May 2022. 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 24 May 2022). 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?

Preoxygenation Duration (time frame: Maximum 8 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 NCT03772574, 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 24 May 2022.