A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Standard Face Mask Preoxygenation
Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.
Intervention: Face Mask preoxygenation (Device)
Optiflow Preoxygenation
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
Intervention: OptiFlow preoxygenation (Device)
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))
Investigators
Anthony Chau
Clinical Assistant Professor
University of British Columbia