Preoxygenation Using THRIVE Versus Facemask in Parturients

Not Applicable

Completed

• Conditions: Preoxygenation
• Interventions: Device: THRIVE preoxygenation; Device: Facemask preoxygenation

• Registration Number: NCT03772574
• Lead Sponsor: University of British Columbia

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-08
• Study First Submitted QC: 2018-12-08
• Study First Posted: 2018-12-11
• Primary Completion: 2019-07-15
• Study Completion: 2020-04-24
• Results First Submitted: 2020-09-08
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-22
• Last Update Submitted: 2022-05-22
• Results First Posted: 2022-05-24
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THRIVE	THRIVE preoxygenation	THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
Facemask	Facemask preoxygenation	Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion to Reach EtO2 of 90 Percent at 7 Minutes	7 minutes of preoxygenation
Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes	3 minutes of pre-oxygenation
Proportion to Reach EtO2 of 90 Percent at 4 Minutes	4 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 5 Minutes	5 minutes of preoxygenation
Proportion to Reach EtO2 of 90 Percent at 8 Minutes	8 minutes of preoxygenation
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)
Proportion to Reach EtO2 of 90 Percent at 6 Minutes	6 minutes of preoxygenation
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).

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada