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Clinical Trials/NCT03310723
NCT03310723
Completed
Not Applicable

A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial

University of British Columbia1 site in 1 country40 target enrollmentNovember 10, 2017
ConditionsPreoxygenation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoxygenation
Sponsor
University of British Columbia
Enrollment
40
Locations
1
Primary Endpoint
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2017
End Date
January 18, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony Chau

Clinical Assistant Professor

University of British Columbia

Eligibility Criteria

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/m
  • Patients who are unable to give informed consent.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow(From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes))

Study Sites (1)

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