Pre-Oxygenation Techniques in Pregnancy

Not Applicable

Completed

• Conditions: Preoxygenation
• Interventions: Device: Face Mask preoxygenation; Device: OptiFlow preoxygenation

• Registration Number: NCT03310723
• Lead Sponsor: University of British Columbia

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 Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Start: 2017-11-10
• Primary Completion: 2018-01-18
• Study Completion: 2018-01-18
• Results First Submitted: 2019-02-25
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-12
• Last Update Submitted: 2020-09-12
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Face Mask Preoxygenation	Face Mask preoxygenation	Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.
Optiflow Preoxygenation	OptiFlow preoxygenation	Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.

Primary Outcome Measures

Name	Time	Method
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow	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 Outcome Measures

Name	Time	Method
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)	Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada