Respiratory FailureNCT02798302
Bag Valve Mask vs Non-rebreather at Flush Rate
A study testing Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific. in people with Respiratory Failure, run by Hennepin Healthcare Research Institute.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >17
Who cannot join
- Pregnant
- Any facial hair more than stubble that might impede a mask seal
About this study
Official title: 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).
- Conditions
- Respiratory Failure
- Being tested
- Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non rebreather | Active comparator | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of expired oxygen
The fraction of expired oxygen will be measured after three minutes of preoxygenation
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Driver, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798302
- Sponsor's protocol ID
- Preox-2
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate
- ClinicalTrials.gov ID
- NCT02798302
- Acronym / sponsor ID
- Preox-2
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >17
Key exclusion criteria (2 listed)
- Pregnant
- Any facial hair more than stubble that might impede a mask seal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Bag valve mask with simulated mask leak, Bag valve mask without leak, Non rebreather |
Primary outcome
Fraction of expired oxygen
Time frame: 3 minutes
The fraction of expired oxygen will be measured after three minutes of preoxygenation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific. in people with Respiratory Failure, run by Hennepin Healthcare Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of expired oxygen (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.