Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist

NCT ID: NCT02841592

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-08-31

Brief Summary

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This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.

Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-rebreather

This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention

Group Type ACTIVE_COMPARATOR

Flush rate oxygen

Intervention Type OTHER

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.

Bag-valve-mask

With each inspiration from the subject, the ventilation bag will be gently squeezed to provide positive pressure and augment the amount of oxygen that is received by the subject for each breath. This group will receive the flush rate oxygen with assist intervention.

Group Type ACTIVE_COMPARATOR

Flush rate oxygen with assist

Intervention Type OTHER

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.

Interventions

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Flush rate oxygen

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.

Intervention Type OTHER

Flush rate oxygen with assist

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.

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

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.

Reference Type DERIVED
PMID: 29089172 (View on PubMed)

Other Identifiers

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16-preox_3

Identifier Type: -

Identifier Source: org_study_id

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