Preoxygenation Using THRIVE Versus Facemask in Parturients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-04-24

Brief Summary

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

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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%.

Conditions

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Preoxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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THRIVE

THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).

Group Type EXPERIMENTAL

THRIVE preoxygenation

Intervention Type DEVICE

Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Facemask

Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).

Group Type ACTIVE_COMPARATOR

Facemask preoxygenation

Intervention Type DEVICE

Standard facemask preoxygenation

Interventions

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Facemask preoxygenation

Standard facemask preoxygenation

Intervention Type DEVICE

THRIVE preoxygenation

Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).

Intervention Type DEVICE

Other Intervention Names

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THRIVE

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.

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes