Pre-Oxygenation Techniques in Pregnancy

Preoxygenation Clinical Trial

— POP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310723
• Other study ID #: H17-01996
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: September 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Preoxygenation

Intervention

Device:
• Face Mask preoxygenation
Standard face mask preoxygenation.
• OptiFlow preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow	Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow	From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing
Secondary	End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow	Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow	From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)