Pre-Oxygenation Techniques in Pregnancy
POP
A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedStudy Start
First participant enrolled
November 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedSeptember 16, 2020
September 1, 2020
2 months
October 4, 2017
February 25, 2019
September 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Study Arms (2)
Standard Face Mask Preoxygenation
ACTIVE COMPARATORTidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.
Optiflow Preoxygenation
EXPERIMENTALTidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
Interventions
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Eligibility Criteria
You may qualify if:
- Healthy (American Society of Anesthesiologists class 1 or 2), pregnant patients ≥36 weeks gestation scheduled for elective Cesarean delivery under neuraxial anesthesia.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Assistant
- Organization
- BC Women's Hospital, Department of Anesthesia
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Chau, MD MMSc
University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 16, 2017
Study Start
November 10, 2017
Primary Completion
January 18, 2018
Study Completion
January 18, 2018
Last Updated
September 16, 2020
Results First Posted
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share