Preoxygenation Using THRIVE Versus Facemask in Parturients

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03772574
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.8
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

Condition or Disease	Intervention/Treatment	Phase
Preoxygenation	Device: Facemask preoxygenation; Device: THRIVE preoxygenation	N/A

Detailed Description

We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 >90%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Jul 15, 2019
• Actual Study Completion Date: Apr 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: THRIVE THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).	Device: THRIVE preoxygenation; Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).; Other Names: THRIVE
Active Comparator: Facemask Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).	Device: Facemask preoxygenation; Standard facemask preoxygenation

Outcome Measures

Primary Outcome Measures

1. Preoxygenation Duration [Maximum 8 minutes]

   Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.

Secondary Outcome Measures

1. Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes [3 minutes of pre-oxygenation]

2. Proportion to Reach EtO2 of 90 Percent at 4 Minutes [4 minutes of preoxygenation]

3. Proportion to Reach EtO2 of 90 Percent at 5 Minutes [5 minutes of preoxygenation]

4. Proportion to Reach EtO2 of 90 Percent at 6 Minutes [6 minutes of preoxygenation]

5. Proportion to Reach EtO2 of 90 Percent at 7 Minutes [7 minutes of preoxygenation]

6. Proportion to Reach EtO2 of 90 Percent at 8 Minutes [8 minutes of preoxygenation]

7. Comfort Score [1 minute after data collection]

   Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)

8. Acceptability Score [1 minute after data collection]

   Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Pregnant patients ≥36 weeks gestation.

• Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.

• American Society of Anesthesiologists (ASA) class 2.

Exclusion Criteria:

• Any medical conditions that are likely to affect gas exchange.

• Obstructed nasal passage.

• Unable to tolerate a tight fitting facemask.

• Body Mass Index ≥40 kg/m2.

• Patients who are in active labor (i.e. cervical dilation ≥4cm).

• 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 - Feb 8, 2019

More Information

Publications

None provided.

• Responsible Party: Anthony Chau, Clinical Assistant Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03772574
• Other Study ID Numbers: H18-02855
• First Posted: Dec 11, 2018
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• 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
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Pre-assignment Detail	91 patients provided informed consent in order to reach the recruitment goal of 80 patients. This is the reason for the discrepancy mentioned in the comments.

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Period Title: Overall Study
STARTED	42	25	24
COMPLETED	40	20	20
NOT COMPLETED	2	5	4

Baseline Characteristics

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask	Total
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	Total of all reporting groups
Overall Participants	40	20	20	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.5 (4.3)	35 (4.1)	35 (4.4)	35.3 (4.2)
Sex: Female, Male (Count of Participants)
Female	40 100%	20 100%	20 100%	80 100%
Male	0 0%	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	40 100%	20 100%	20 100%	80 100%
Gravidity (Pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pregnancies]	2	2	2	2
Parity (births) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [births]	1	1	1	1
Gestational age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	38.6 (1.0)	38.7 (1.1)	39.1 (0.6)	38.8 (0.92)
Baseline respiratory rate (breaths/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [breaths/min]	11.9 (3.7)	14.5 (4.1)	13.3 (3.1)	12.9 (3.8)
Baseline End Tidal Oxygen (ETO2) (Percent of oxygen in expired breath) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent of oxygen in expired breath]	15.7 (1.2)	15.7 (0.9)	15.8 (1.0)	15.7 (1.1)
Baseline Heart Rate (bpm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [bpm]	74.4 (10.8)	76.1 (9.7)	75.2 (13.9)	75.1 (11.3)
Baseline Oxygen Saturation (SPO2) (percent of hemoglobin carrying oxygen) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent of hemoglobin carrying oxygen]	98.0 (1.5)	98.4 (1.4)	98.5 (1.4)	98.2 (1.4)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.1 (3.7)	29.5 (4.8)	30.4 (3.8)	29.5 (4.0)

Outcome Measures

1. Primary Outcome

Title	Preoxygenation Duration
Description	Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
Time Frame	Maximum 8 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	40	20	20
Mean (95% Confidence Interval) [minutes]	3.6	NA	NA

2. Secondary Outcome

Title	Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
Time Frame	3 minutes of pre-oxygenation

Outcome Measure Data

Analysis Population Description

Patients selected to receive 3 minutes of pre-oxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	14	2	1
Count of Participants [Participants]	10 25%	0 0%	0 0%

3. Secondary Outcome

Title	Proportion to Reach EtO2 of 90 Percent at 4 Minutes
Time Frame	4 minutes of preoxygenation

Outcome Measure Data

Analysis Population Description

Patients assigned to recieve 4 minutes of pre-oxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	26	3	5
Count of Participants [Participants]	26 65%	2 10%	4 20%

4. Secondary Outcome

Title	Proportion to Reach EtO2 of 90 Percent at 5 Minutes
Time Frame	5 minutes of preoxygenation

Outcome Measure Data

Analysis Population Description

Patients assigned to receive 5 minutes of pre-oxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	0	1	1
Count of Participants [Participants]	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Proportion to Reach EtO2 of 90 Percent at 6 Minutes
Time Frame	6 minutes of preoxygenation

Outcome Measure Data

Analysis Population Description

Patients assigned to receive 6 minutes of preoxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	0	1	1
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Proportion to Reach EtO2 of 90 Percent at 7 Minutes
Time Frame	7 minutes of preoxygenation

Outcome Measure Data

Analysis Population Description

Patients assigned to receive 7 minutes of preoxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	0	1	1
Count of Participants [Participants]	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Proportion to Reach EtO2 of 90 Percent at 8 Minutes
Time Frame	8 minutes of preoxygenation

Outcome Measure Data

Analysis Population Description

patients assigned to receive 8 minuets of pre-oxygenation

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	0	12	11
Count of Participants [Participants]	0 0%	1 5%	5 25%

8. Secondary Outcome

Title	Comfort Score
Description	Patients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)
Time Frame	1 minute after data collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	40	20	20
Median (Inter-Quartile Range) [Likert Score]	4	4	4

9. Secondary Outcome

Title	Acceptability Score
Description	Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
Time Frame	1 minute after data collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Facemask	THRIVE	THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Measure Participants	40	20	20
Median (Inter-Quartile Range) [Likert Score]	5	4.5	5

Adverse Events

Time Frame	7 months
Adverse Event Reporting Description	Patients are not at risk of any adverse events other than some discomfort during preoxygentaion. The study team was careful to avoid complications of pressure related damage to the lungs, by limiting the period of time patients were exposed to high flow oxygen to 8 minutes.
Arm/Group Title	Standard Facemask		THRIVE		THRIVE and Facemask
Arm/Group Description	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation		THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).		THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
All Cause Mortality
	Standard Facemask		THRIVE		THRIVE and Facemask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/25 (0%)		0/24 (0%)
Serious Adverse Events
	Standard Facemask		THRIVE		THRIVE and Facemask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Standard Facemask		THRIVE		THRIVE and Facemask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/25 (0%)		0/24 (0%)

Limitations/Caveats

Our results are specific to healthy parturients using standard facemasks, or a high oxygen flow rate of 50L/min, and cannot be generalized to other techniques or populations. 9 parturients left the study due to discomfort, which may bias outcomes

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.