Respiratory FailureNCT02708862
Four Methods of Pre-oxygenation
A study testing Preoxygenation in people with Respiratory Failure, run by Hennepin Healthcare Research Institute.
Trial summary
Four methods of preoxygenation will be compared in healthy volunteers 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?
- Preoxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Over 18 years old
Who cannot join
- Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
- pregnant
About this study
Official title: Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers
Four methods of preoxygenation will be compared in healthy volunteers
Read the detailed description
After informed consent, each volunteer will undergo the following techniques:
Simple mask at "flush" flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min
After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor
- Conditions
- Respiratory Failure
- Being tested
- Preoxygenation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreoxygenationDevice
After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
| Study group | Role | What they receive |
|---|---|---|
| Preoxygenation | Experimental | All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes Receives: Device: Preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Oxygen Concentration
Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.
Measured: Immediately after 3 minutes of oxygen supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT02708862
- Sponsor's protocol ID
- Preox
- Status last verified
- May 2019
- First submitted
- 4 Mar 2016
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Driver BE, Prekker ME, Kornas RL, Cales EK, Reardon RF. Flush Rate Oxygen for Emergency Airway Preoxygenation. Ann Emerg Med. 2017 Jan;69(1):1-6. doi: 10.1016/j.annemergmed.2016.06.018. Epub 2016 Aug 10.
PubMed 27522310
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02708862
- Acronym / sponsor ID
- Preox
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Four methods of preoxygenation will be compared in healthy volunteers
Detailed description
After informed consent, each volunteer will undergo the following techniques:
Simple mask at "flush" flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min
After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoxygenation | Experimental | Device: PreoxygenationAll participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years old
Key exclusion criteria (2 listed)
- Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
- pregnant
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 |
|---|---|---|
| PreoxygenationAfter 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes | Device | Preoxygenation |
Primary outcome
Exhaled Oxygen Concentration
Time frame: Immediately after 3 minutes of oxygen supplementation
Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27522310Driver BE, Prekker ME, Kornas RL, Cales EK, Reardon RF. Flush Rate Oxygen for Emergency Airway Preoxygenation. Ann Emerg Med. 2017 Jan;69(1):1-6. doi: 10.1016/j.annemergmed.2016.06.018. Epub 2016 Aug 10.
- Individual participant dataSharing planned: Undecided
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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 Preoxygenation 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 18 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exhaled Oxygen Concentration (time frame: Immediately after 3 minutes of oxygen supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708862, which also lists 1 linked publication.
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 18 Jun 2019.