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Completed

NCT Number: NCT03310723

Pre-Oxygenation Techniques in Pregnancy

A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.

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Key information

Conditions

Preoxygenation

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Face Mask preoxygenation

Device

Standard face mask preoxygenation.

OptiFlow preoxygenation

Device

Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Other names: THRIVE

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: POP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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