EducationNCT01720017
Impact of Manikin Training on Airtraq Avant Learning Curve in Predicted Difficult Airways
A study testing Preclinical Manikin Training and Inservice Training in people with Education and Training, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall purpose of this study is to assess the impact of preclinical airway manikin training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) on the clinical learning curve of using the device/system in airways with predictors for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Preclinical Manikin Training and Inservice Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2014
- 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
- anesthesia providers (i.e., anesthesia residents, anesthetists, and staff anesthesiologists)
Who cannot join
- < 18 years of age
- non-english speaking
- unwilling to sign a study consent form
- related financially or otherwise to the Airtraq Avant manufacturer will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: The Impact of Airway Manikin Training on the Airtraq Avant and Wireless Monitor System Learning Curve in Airways With Predictors for Difficult Intubation
The overall purpose of this study is to assess the impact of preclinical airway manikin training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) on the clinical learning curve of using the device/system in airways with predictors for difficult intubation.
The investigators hypothesize that the clinical learning curve in airways with predictors for difficult intubation will be shorter for study subjects (operators) who undergo preclinical manikin training under simulated difficult airway conditions compared to Study subjects (operators) who do not receive this training. The clinical learning curve is characterized by procedure times and first attempt success rates on successive uses of the Airtraq Avant and Wireless Monitor System in patients with at least one predictor for difficult intubation.
Read the detailed description
Tracheal intubation (placement of a breathing tube below the vocal cords into the trachea) is an essential skill for the anesthesia provider. Training on the use of new technology (i.e., procedural training), including video/optical laryngoscopy (e.g., the Airtraq Avant, Glidescope, and similar devices) usually occurs under the tutelage of learned practitioners, while caring for actual patients in the operating room, not during didactic sessions in a classroom. Although the use of airway trainers (manikins) has led to improved clinical learning curves for the use of some airway devices, it is not known if training on the use of the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) will improve the learning curve of using the device/system clinically in in patients with at least one predictor of difficult intubation.
The specific aim of this study is to compare the clinical learning curve, characterized by procedure times and first attempt success rates on successive uses, of using the Airtraq Avant and Wireless Monitor System in patients with at least one predictor for diffcult intubation between anesthesia providers who receive preclinical airway manikin training under simulated difficult airway conditions (c-collar and swollen tongue) and those who do not. The subjects of this study are anesthesia providers enrolled in the study.
Secondary specific aims include assessing the impact of preclinical airway manikin training under simulated difficult airway conditions on glottic view grade, glottic view attainment maneuvers, ease of Airtraq Avant insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical usefulness in airways with predictors of difficult intubation.
- Being tested
- Preclinical Manikin Training, Inservice Training
- Keywords
- Airtraq, laryngoscope, airway, difficult, training, manikin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preclinical Manikin TrainingOther
During the preclinical manikin training, each subject will perform 10 intubations in a manikin with a difficult airway simulated by swelling the manikin tongue and placing it in a cervical collar.
Inservice TrainingOther
Inservice training will include review of a product information handout and a video demonstration.
| Study group | Role | What they receive |
|---|---|---|
| Inservice Training Only | Active comparator | Inservice training will include review of a product information handout and a video demonstration. Specific attention will be given to (1) describing each system component and its operation, (2) attaching the wireless camera head and coordinating channel selection with the monitor, (3) turning on the Airtraq Avant light and device preparation for use, (4) Airtraq Avant insertion into the patient's mouth and advancement into the hypopharynx (deep in the throat) to obtain a view of the vocal cords, (5) use of standard lift and rotation movements to optimize the vocal cord view, (6) tracheal tube advancement through the vocal cords tracheal intubation, (7) standard methods for confirmation of correct tracheal tube placement, (8) tracheal tube removal from the Airtraq Avant and the Airtraq Avant removal from the patient's mouth, and (9) disposal of the disposable blade and cleaning of the reusable optics insert. Receives: Other: Inservice Training |
| Inservice and Manikin Training | Experimental | Study subjects in this group will receive the standard inservice training described above, as well as, preclinical manikin training on use of the Airtraq Avant and Wireless Monitor System in simulated difficult airway conditions (swollen tongue and cervical collar). During the preclinical manikin training, each subject will perform 10 intubations. Performance characteristics including attempts for successful Airtraq Avant insertion, glottic view obtained, ease of insertion, ease of tracheal intubation, time required for tracheal intubation, and attempts for successful tracheal intubation will be recorded for each intubation. Receives: Other: Preclinical Manikin Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Repeated measure of intubation efficiency using the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the time from placing the videolaryngoscope into the patient's mouth to passage of the tracheal tube balloon below the vocal cords.
Measured: Within the first 3 minutes of 20 successive intubations.
Secondary outcomes (1)
First attempt success rate
Cumulative measure of intubation success on first attempt over 20 successive uses of the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the videolaryngoscope from the patient's mouth.
Measured: Within the first 3 minutes of 20 successive intubations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Difficulty was encountered with the subjects completing their required 20 intubations in patients with at least one predictor of difficult intubation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E Galgon, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720017
- Sponsor's protocol ID
- 2012-0636
- Status last verified
- May 2014
- First submitted
- 24 Oct 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Airway Manikin Training on the Airtraq Avant and Wireless Monitor System Learning Curve in Airways With Predictors for Difficult Intubation
- ClinicalTrials.gov ID
- NCT01720017
- Acronym / sponsor ID
- 2012-0636
- Keywords
- Airtraq, laryngoscope, airway, difficult, training, manikin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty was encountered with the subjects completing their required 20 intubations in patients with at least one predictor of difficult intubation.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Nov 2012 (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 purpose of this study is to assess the impact of preclinical airway manikin training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) on the clinical learning curve of using the device/system in airways with predictors for difficult intubation.
The investigators hypothesize that the clinical learning curve in airways with predictors for difficult intubation will be shorter for study subjects (operators) who undergo preclinical manikin training under simulated difficult airway conditions compared to Study subjects (operators) who do not receive this training. The clinical learning curve is characterized by procedure times and first attempt success rates on successive uses of the Airtraq Avant and Wireless Monitor System in patients with at least one predictor for difficult intubation.
Detailed description
Tracheal intubation (placement of a breathing tube below the vocal cords into the trachea) is an essential skill for the anesthesia provider. Training on the use of new technology (i.e., procedural training), including video/optical laryngoscopy (e.g., the Airtraq Avant, Glidescope, and similar devices) usually occurs under the tutelage of learned practitioners, while caring for actual patients in the operating room, not during didactic sessions in a classroom. Although the use of airway trainers (manikins) has led to improved clinical learning curves for the use of some airway devices, it is not known if training on the use of the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions (c-collar and swollen tongue) will improve the learning curve of using the device/system clinically in in patients with at least one predictor of difficult intubation.
The specific aim of this study is to compare the clinical learning curve, characterized by procedure times and first attempt success rates on successive uses, of using the Airtraq Avant and Wireless Monitor System in patients with at least one predictor for diffcult intubation between anesthesia providers who receive preclinical airway manikin training under simulated difficult airway conditions (c-collar and swollen tongue) and those who do not. The subjects of this study are anesthesia providers enrolled in the study.
Secondary specific aims include assessing the impact of preclinical airway manikin training under simulated difficult airway conditions on glottic view grade, glottic view attainment maneuvers, ease of Airtraq Avant insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical usefulness in airways with predictors of difficult intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inservice Training Only | Active comparator | Other: Inservice TrainingInservice training will include review of a product information handout and a video demonstration. Specific attention will be given to (1) describing each system component and its operation, (2) attaching the wireless camera head and coordinating channel selection with the monitor, (3) turning on the Airtraq Avant light and device preparation for use, (4) Airtraq Avant insertion into the patient's mouth and advancement into the hypopharynx (deep in the throat) to obtain a view of the vocal cords, (5) use of standard lift and rotation movements to optimize the vocal cord view, (6) tracheal tube advancement through the vocal cords tracheal intubation, (7) standard methods for confirmation of correct tracheal tube placement, (8) tracheal tube removal from the Airtraq Avant and the Airtraq Avant removal from the patient's mouth, and (9) disposal of the disposable blade and cleaning of the reusable optics insert. |
| Inservice and Manikin Training | Experimental | Other: Preclinical Manikin TrainingStudy subjects in this group will receive the standard inservice training described above, as well as, preclinical manikin training on use of the Airtraq Avant and Wireless Monitor System in simulated difficult airway conditions (swollen tongue and cervical collar). During the preclinical manikin training, each subject will perform 10 intubations. Performance characteristics including attempts for successful Airtraq Avant insertion, glottic view obtained, ease of insertion, ease of tracheal intubation, time required for tracheal intubation, and attempts for successful tracheal intubation will be recorded for each intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anesthesia providers (i.e., anesthesia residents, anesthetists, and staff anesthesiologists)
Key exclusion criteria (4 listed)
- < 18 years of age
- non-english speaking
- unwilling to sign a study consent form
- related financially or otherwise to the Airtraq Avant manufacturer will not be eligible.
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 |
|---|---|---|
| Preclinical Manikin TrainingDuring the preclinical manikin training, each subject will perform 10 intubations in a manikin with a difficult airway simulated by swelling the manikin tongue and placing it in a cervical collar. | Other | Inservice and Manikin Training |
| Inservice TrainingInservice training will include review of a product information handout and a video demonstration. | Other | Inservice Training Only |
Primary outcome
Intubation time
Time frame: Within the first 3 minutes of 20 successive intubations.
Repeated measure of intubation efficiency using the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the time from placing the videolaryngoscope into the patient's mouth to passage of the tracheal tube balloon below the vocal cords.
1 secondary outcome
First attempt success rate
Time frame: Within the first 3 minutes of 20 successive intubations.
Results and safety
The study was stopped early (reason given: Difficulty was encountered with the subjects completing their required 20 intubations in patients with at least one predictor of difficult intubation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Related trials for Education
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial
First Aid, Health Education in Schoolchildren
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.
Richard E Galgon, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preclinical Manikin Training and Inservice Training in people with Education and Training, run by University of Wisconsin, Madison 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 4 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: stopped early, as of the sponsor's last update on 2 Oct 2015. 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 was stopped early (reason given: Difficulty was encountered with the subjects completing their required 20 intubations in patients with at least one predictor of difficult intubation.). Results are not available in the source record.
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?
Intubation time (time frame: Within the first 3 minutes of 20 successive intubations.). 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 2 Oct 2015.