NCT02798302

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

June 6, 2016

Last Update Submit

January 28, 2018

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Fraction of expired oxygen

    The fraction of expired oxygen will be measured after three minutes of preoxygenation

    3 minutes

Study Arms (3)

Non rebreather

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

Bag valve mask without leak

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

Bag valve mask with simulated mask leak

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

Interventions

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

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

Bag valve mask with simulated mask leakBag valve mask without leakNon rebreather

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>17

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Director

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 14, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01