Pre-Oxygenation Techniques in Pregnancy (POP)

September 12, 2020 updated by: Anthony Chau, University of British Columbia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy (American Society of Anesthesiologists class 1 or 2), pregnant patients ≥36 weeks gestation scheduled for elective Cesarean delivery under neuraxial anesthesia.

Exclusion Criteria:

  • 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.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Face Mask Preoxygenation
Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.
Device: Face Mask preoxygenation
Standard face mask preoxygenation.
Experimental: Optiflow Preoxygenation
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
Device: OptiFlow preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Other Names:
  • THRIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow
From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)

Collaborators and Investigators

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

Sponsor

University of British Columbia

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)

November 10, 2017

Primary Completion (Actual)

January 18, 2018

Study Completion (Actual)

January 18, 2018

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • H17-01996

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.

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