IntubationUSE AP OXNCT02961933
Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation
A study testing Apneic oxygenation and Pre-oxgenation with NRB, NIPPV, BVM in people with Intubation, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Apneic oxygenation and Pre-oxgenation with NRB, NIPPV, BVM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)
Who cannot join
- Known prisoners
- Patients in cardiac arrest
- Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie Aston, MBA, RT, 801-507-4606, Valerie.Aston@imail.org
Rob Bryant, MD
About this study
This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.
- Conditions
- Intubation
- Being tested
- Apneic oxygenation, Pre-oxgenation with NRB, NIPPV, BVM
- Keywords
- hypoxemia, intubation, apneic oxygenation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic oxygenationOther
Nasal cannula apneic oxygenation
Pre-oxgenation with NRB, NIPPV, BVMOther
Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask
| Study group | Role | What they receive |
|---|---|---|
| Apneic oxygenation | Experimental | Not described Receives: Other: Apneic oxygenation |
| non-apneic oxygenation | Active comparator | Not described Receives: Other: Pre-oxgenation with NRB, NIPPV, BVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success without hypoxemia
Measured: 10 minutes
Secondary outcomes (4)
Change in peri-intubation saturation
Measured: 0, 30, 60 and 120 seconds
Saturation at time of tube placement
Measured: 10 minutes
Time to desaturation <93%
Measured: measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes
Saturation at post intubation
Measured: 0, 30, 60, and 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2020
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Robert Bryant, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961933
- Sponsor's protocol ID
- 1050200
- Acronym
- USE AP OX
- Status last verified
- Feb 2020
- First submitted
- 1 Nov 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation
- ClinicalTrials.gov ID
- NCT02961933
- Acronym / sponsor ID
- USE AP OX / 1050200
- Conditions
- Intubation
- Keywords
- hypoxemia, intubation, apneic oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah
- Study start
- Dec 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Nov 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.
This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apneic oxygenation | Experimental | Other: Apneic oxygenation |
| non-apneic oxygenation | Active comparator | Other: Pre-oxgenation with NRB, NIPPV, BVM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)
Key exclusion criteria (3 listed)
- Known prisoners
- Patients in cardiac arrest
- Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).
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 |
|---|---|---|
| Apneic oxygenationNasal cannula apneic oxygenation | Other | Apneic oxygenation |
| Pre-oxgenation with NRB, NIPPV, BVMPre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask | Other | non-apneic oxygenation |
Primary outcome
First pass success without hypoxemia
Time frame: 10 minutes
4 secondary outcomes
Change in peri-intubation saturation
Time frame: 0, 30, 60 and 120 seconds
Saturation at time of tube placement
Time frame: 10 minutes
Time to desaturation <93%
Time frame: measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes
Saturation at post intubation
Time frame: 0, 30, 60, and 120 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Robert Bryant, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneic oxygenation and Pre-oxgenation with NRB, NIPPV, BVM in people with Intubation, run by Intermountain Health Care, Inc. at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Aston, MBA, RT (801-507-4606, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success without hypoxemia (time frame: 10 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 11 Feb 2020.