- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720017
Impact of Manikin Training on Airtraq Avant Learning Curve in Predicted Difficult Airways
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- anesthesia providers (i.e., anesthesia residents, anesthetists, and staff anesthesiologists)
Exclusion Criteria:
- < 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Inservice Training Only
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.
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Inservice training will include review of a product information handout and a video demonstration.
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Experimental: Inservice and Manikin Training
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation time
Time Frame: Within the first 3 minutes of 20 successive intubations.
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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.
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Within the first 3 minutes of 20 successive intubations.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First attempt success rate
Time Frame: Within the first 3 minutes of 20 successive intubations.
|
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.
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Within the first 3 minutes of 20 successive intubations.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glottic view grade
Time Frame: Within the first 3 minutes of 20 successive intubations
|
Determined as the best view obtained when attempting to use the Airtraq Avant and Wireless Monitor System to pass a tracheal tube below a patient's vocal cords.
Grade 1 = full view of vocal cords.
Grade 2a = partial view of vocal cords.
Grade 2b = no vocal cords seen.
Arytenoids visible.
Grade 3 = No view of the vocal cords or arytenoids.
Anterior epiglottis visible.
Grade 4 = Only soft tissue visible.
No view of the periglottic structures, including the epiglottis, is present.
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Within the first 3 minutes of 20 successive intubations
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Ease of Airtraq Avant insertion Avant insertion
Time Frame: Within the first 3 minutes of 20 successive intubations
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Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to insert the Airtraq Avant into a patient's mouth.
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Within the first 3 minutes of 20 successive intubations
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Ease of tracheal intubation
Time Frame: Within the first 3 minutes of 20 successive intubations
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Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to pass a tracheal tube below a patient's vocal cords using the Airtraq Avant and Wireless Monitor System.
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Within the first 3 minutes of 20 successive intubations
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Mechanisms of tracheal tube insertion impediment
Time Frame: Within the first 3 minutes of 20 successive intubations
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Observational description of features causing impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid).
Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using the Aitraq Avant and Wireless Monitor System.
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Within the first 3 minutes of 20 successive intubations
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Overall clinical usefulness
Time Frame: Within the first 3 minutes of 20 successive intubations
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Recorded as excellent, good, fair, or inadequate by the study subject when using the Airtraq Avant and Wireless Monitor System to place a tracheal tube below a patient's vocal cords.
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Within the first 3 minutes of 20 successive intubations
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard E Galgon, MD, MS, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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