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Pre-Oxygenation Techniques in Pregnancy (POP)

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

Preoxygenation

Treatments

Device: OptiFlow preoxygenation
Device: Face Mask preoxygenation

Study type

Interventional

Funder types

Other

Identifiers

NCT03310723
H17-01996

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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