POP: Pre-Oxygenation Techniques in Pregnancy

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03310723
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 17.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preoxygenation	Device: Face Mask preoxygenation; Device: OptiFlow preoxygenation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Pre-oxygenation Techniques in Pregnant Patients Prior to a Cesarean Delivery - A Randomized Clinical Trial
• Actual Study Start Date: Nov 10, 2017
• Actual Primary Completion Date: Jan 18, 2018
• Actual Study Completion Date: Jan 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Face Mask Preoxygenation Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.	Device: Face Mask preoxygenation; Standard face mask preoxygenation.
Experimental: Optiflow Preoxygenation Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.	Device: OptiFlow preoxygenation; Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).; Other Names: THRIVE

Outcome Measures

Primary Outcome Measures

1. 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

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)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Women's Hospital	Vancouver	British Columbia	Canada	V6H 3N1

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Anton Chau, MD MMSc, University of British Columbia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 23, 2019

More Information

Publications

None provided.

• Responsible Party: Anthony Chau, Clinical Assistant Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03310723
• Other Study ID Numbers: H17-01996
• First Posted: Oct 16, 2017
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Standard Face Mask Preoxygenation	Optiflow Preoxygenation
Arm/Group Description	Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min. Face Mask preoxygenation: Standard face mask preoxygenation.	Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	17
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Standard Face Mask Preoxygenation	Optiflow Preoxygenation	Total
Arm/Group Description	Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min. Face Mask preoxygenation: Standard face mask preoxygenation.	Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	Total of all reporting groups
Overall Participants	20	17	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (4.3)	34.6 (5.3)	34.7 (4.8)
Sex: Female, Male (Count of Participants)
Female	20 100%	17 100%	37 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	20 100%	17 100%	37 100%
Baseline end-tidal oxygen concentration (EtO2) (Percentage units) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage units]	15.9 (1.2)	15.9 (1.5)	15.9 (1.35)

Outcome Measures

1. Primary Outcome

Title	End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
Description	Concentration of oxygen at the end of a breath following 3 minutes of 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Face Mask Preoxygenation	Optiflow Preoxygenation
Arm/Group Description	Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min. Face Mask preoxygenation: Standard face mask preoxygenation.	Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	20	17
Median (Inter-Quartile Range) [Percentage units of end-tidal oxygen]	91.0	87.4

2. Secondary Outcome

Title	End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow
Description	Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow
Time Frame	From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Face Mask Preoxygenation	Optiflow Preoxygenation
Arm/Group Description	Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min. Face Mask preoxygenation: Standard face mask preoxygenation.	Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	20	17
Median (Inter-Quartile Range) [Percentage units]	91.8	85.9

Adverse Events

Time Frame	Adverse event data were collected during study procedures (i.e., from baseline measurements to end of pre-oxygenation at 3 minutes).
Arm/Group Title	Standard Face Mask Preoxygenation		Optiflow Preoxygenation
Arm/Group Description	Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min. Face Mask preoxygenation: Standard face mask preoxygenation.		Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
All Cause Mortality
	Standard Face Mask Preoxygenation		Optiflow Preoxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Standard Face Mask Preoxygenation		Optiflow Preoxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Standard Face Mask Preoxygenation		Optiflow Preoxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.