Preoxygenation Using THRIVE Versus Facemask in Parturients

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

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

Official Title
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Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients

Conditions
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Preoxygenation

Intervention / Treatment
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* Device: Facemask preoxygenation
* Device: THRIVE preoxygenation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 6 Minutes |  | 6 minutes of preoxygenation | 
| Proportion to Reach EtO2 of 90 Percent at 7 Minutes |  | 7 minutes of preoxygenation | 
| Proportion to Reach EtO2 of 90 Percent at 8 Minutes |  | 8 minutes of preoxygenation | 
| Comfort Score | 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) | 1 minute after data collection | 
| Acceptability Score | Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable). | 1 minute after data collection |