Bag Valve Mask vs Non-rebreather at Flush Rate

January 28, 2018 updated by: Brian Driver, Hennepin Healthcare Research Institute

Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >17

Exclusion Criteria:

  • Pregnant
  • Any facial hair more than stubble that might impede a mask seal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non rebreather
Other: 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.
Active Comparator: Bag valve mask without leak
Other: 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.
Active Comparator: Bag valve mask with simulated mask leak
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of expired oxygen
Time Frame: 3 minutes
The fraction of expired oxygen will be measured after three minutes of preoxygenation
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preox-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe