NCT03772574

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 24, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

December 8, 2018

Results QC Date

September 8, 2020

Last Update Submit

May 22, 2022

Conditions

Preoxygenation

Outcome Measures

Primary Outcomes (1)

  • Preoxygenation Duration

    Duration to achieve EtO2 \>=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.

    Maximum 8 minutes

Secondary Outcomes (8)

  • Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes

    3 minutes of pre-oxygenation

  • Proportion to Reach EtO2 of 90 Percent at 4 Minutes

    4 minutes of preoxygenation

  • Proportion to Reach EtO2 of 90 Percent at 5 Minutes

    5 minutes of preoxygenation

  • Proportion to Reach EtO2 of 90 Percent at 6 Minutes

    6 minutes of preoxygenation

  • Proportion to Reach EtO2 of 90 Percent at 7 Minutes

    7 minutes of preoxygenation

  • +3 more secondary outcomes

Study Arms (2)

THRIVE

EXPERIMENTAL

THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).

Device: THRIVE preoxygenation

Facemask

ACTIVE COMPARATOR

Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).

Device: Facemask preoxygenation

Interventions

Facemask preoxygenationDEVICE

Standard facemask preoxygenation

Facemask
THRIVE preoxygenationDEVICE

Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Also known as: THRIVE
THRIVE

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32048278DERIVED

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

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

Results Point of Contact

Title
Dr. Anthony Chau
Organization
BC Women's Hospital
anton.chau@ubc.ca
604-875-2158

Study Officials

  • Anton Chau, MD MMSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 8, 2018

First Posted

December 11, 2018

Study Start

December 1, 2018

Primary Completion

July 15, 2019

Study Completion

April 24, 2020

Last Updated

May 24, 2022

Results First Posted

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)