Bag Valve Mask vs Non-rebreather at Flush Rate

NCT ID: NCT02798302

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

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Healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).

Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Non rebreather

Group Type ACTIVE_COMPARATOR

Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.

Intervention Type OTHER

A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.

Bag valve mask without leak

Group Type ACTIVE_COMPARATOR

Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.

Intervention Type OTHER

A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.

Bag valve mask with simulated mask leak

Group Type ACTIVE_COMPARATOR

Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.

Intervention Type OTHER

A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.

Interventions

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Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.

A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>17

Exclusion Criteria

* Pregnant
* Any facial hair more than stubble that might impede a mask seal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Brian Driver

Associate Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Preox-2

Identifier Type: -

Identifier Source: org_study_id

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