Impact of Manikin Training on Airtraq Avant Learning Curve in Predicted Difficult Airways

Education Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720017
• Other study ID #: 2012-0636
• Status: Terminated
• Phase: N/A
• First received: October 24, 2012
• Last updated: September 30, 2015
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Education
• Manikin
• Training

Intervention

Other:
• Preclinical Manikin Training
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 Training
Inservice training will include review of a product information handout and a video demonstration.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glottic view grade	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.	Within the first 3 minutes of 20 successive intubations	No
Other	Ease of Airtraq Avant insertion Avant insertion	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.	Within the first 3 minutes of 20 successive intubations	No
Other	Ease of tracheal intubation	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.	Within the first 3 minutes of 20 successive intubations	No
Other	Mechanisms of tracheal tube insertion impediment	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.	Within the first 3 minutes of 20 successive intubations	No
Other	Overall clinical usefulness	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.	Within the first 3 minutes of 20 successive intubations	No
Primary	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.	Within the first 3 minutes of 20 successive intubations.	No
Secondary	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.	Within the first 3 minutes of 20 successive intubations.	No