Airway Management AssessmentNCT02097498
Improving Patient Safety Through Simulation Research
A study testing Directed feedback and Basic Videolaryngoscopy Videos in people with Airway Management Assessment, run by Ohio State University at 1 site in United States.
Trial summary
The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Management Assessment
- What is being tested?
- Directed feedback and Basic Videolaryngoscopy Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently certified central Ohio paramedics
Who cannot join
- Refusal to participate
- Non-certified paramedics
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study
The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.
- Conditions
- Airway Management Assessment
- Being tested
- Directed feedback, Basic Videolaryngoscopy Videos
- Keywords
- Simulation, Enhance, Safety, Proficiency, Paramedics., Airway Management, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directed feedbackOther
Group will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video
Basic Videolaryngoscopy VideosOther
Group will watch a series of educational videos related to common airway management errors.
| Study group | Role | What they receive |
|---|---|---|
| Simulation only | No intervention | One group will be randomized to receive simulation training similar to that required for certification. Paramedics in this group will then complete a second simulation scenario |
| Directed feedback | Experimental | One group will review their baseline simulation scenario with a member of the research staff while providing specific feedback for errors made during the first simulation. Paramedics in this group will then complete a second simulation scenario. Receives: Other: Directed feedback |
| Basic Videolaryngoscopy | Experimental | One group will review a series of instructional videos related to common airway management errors. Paramedics in this group will then complete a second simulation scenario. Receives: Other: Basic Videolaryngoscopy Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and validation of an airway management assessment tool
Employing a team of psychometric, human factors, and airway management experts, we propose to make refinements to our assessment tool so that it has objective measurement criteria, takes timing and sequencing of actions into account, provides reproducible scores, has high inter-rater reliability, and can be a valid measure of paramedic airway management proficiency and safety.
Measured: 3 years
Secondary outcomes (1)
Development of educational interventions to improve skill retention
The paramedics will be reassessed at 12 to determine whether skill level was maintained.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Management AssessmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas E. Terndrup, Ohio State University
- Investigators
- Thomas E Terndrup, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097498
- Sponsor's protocol ID
- 2013H0226
- Status last verified
- Sep 2016
- First submitted
- 18 Feb 2014
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study
- ClinicalTrials.gov ID
- NCT02097498
- Acronym / sponsor ID
- 2013H0226
- Conditions
- Airway Management Assessment
- Keywords
- Simulation, Enhance, Safety, Proficiency, Paramedics., Airway Management, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Mar 2014 (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.
The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simulation only | No intervention | –One group will be randomized to receive simulation training similar to that required for certification. Paramedics in this group will then complete a second simulation scenario |
| Directed feedback | Experimental | Other: Directed feedbackOne group will review their baseline simulation scenario with a member of the research staff while providing specific feedback for errors made during the first simulation. Paramedics in this group will then complete a second simulation scenario. |
| Basic Videolaryngoscopy | Experimental | Other: Basic Videolaryngoscopy VideosOne group will review a series of instructional videos related to common airway management errors. Paramedics in this group will then complete a second simulation scenario. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Currently certified central Ohio paramedics
Key exclusion criteria (2 listed)
- Refusal to participate
- Non-certified paramedics
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 |
|---|---|---|
| Directed feedbackGroup will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video | Other | Directed feedback |
| Basic Videolaryngoscopy VideosGroup will watch a series of educational videos related to common airway management errors. | Other | Basic Videolaryngoscopy |
Primary outcome
Development and validation of an airway management assessment tool
Time frame: 3 years
Employing a team of psychometric, human factors, and airway management experts, we propose to make refinements to our assessment tool so that it has objective measurement criteria, takes timing and sequencing of actions into account, provides reproducible scores, has high inter-rater reliability, and can be a valid measure of paramedic airway management proficiency and safety.
1 secondary outcome
Development of educational interventions to improve skill retention
Time frame: 2 years
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 28 Sep 2016.
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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.
Thomas E Terndrup, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directed feedback and Basic Videolaryngoscopy Videos in people with Airway Management Assessment, run by Ohio State University 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 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 28 Sep 2016. 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?
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?
Development and validation of an airway management assessment tool (time frame: 3 years). 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 28 Sep 2016.