Preoxygenation Using THRIVE Versus Facemask in Parturients

May 22, 2022 updated by: Anthony Chau, University of British Columbia

Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: THRIVE
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
Device: THRIVE preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Other Names:
  • THRIVE
ACTIVE_COMPARATOR: Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Device: Facemask preoxygenation
Standard facemask preoxygenation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
Time Frame: 3 minutes of pre-oxygenation
3 minutes of pre-oxygenation
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
Time Frame: 4 minutes of preoxygenation
4 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
Time Frame: 5 minutes of preoxygenation
5 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
Time Frame: 6 minutes of preoxygenation
6 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
Time Frame: 7 minutes of preoxygenation
7 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
Time Frame: 8 minutes of preoxygenation
8 minutes of preoxygenation
Comfort Score
Time Frame: 1 minute after data collection
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)
1 minute after data collection
Acceptability Score
Time Frame: 1 minute after data collection
Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
1 minute after data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

July 15, 2019

Study Completion (ACTUAL)

April 24, 2020

Study Registration Dates

First Submitted

December 8, 2018

First Submitted That Met QC Criteria

December 8, 2018

First Posted (ACTUAL)

December 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18-02855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preoxygenation

Clinical Trials on THRIVE preoxygenation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe