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

NCT01720017 | Terminated

• 1 other identifier: 2012-0636
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Education; Training; Manikin

Keywords

Airtraq; laryngoscope; airway; difficult; training; manikin

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• First attempt success rate

  Within the first 3 minutes of 20 successive intubations.

Other Outcomes (5)

• Glottic view grade

  Within the first 3 minutes of 20 successive intubations

• Ease of Airtraq Avant insertion Avant insertion

  Within the first 3 minutes of 20 successive intubations

• Ease of tracheal intubation

  Within the first 3 minutes of 20 successive intubations

Study Arms (2)

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.

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.

Other: Preclinical Manikin Training

Interventions

Preclinical Manikin Training OTHER

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 and Manikin Training

Inservice Training OTHER

Inservice training will include review of a product information handout and a video demonstration.

Inservice Training Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• anesthesia providers (i.e., anesthesia residents, anesthetists, and staff anesthesiologists)

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Richard E Galgon, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 2, 2015

Record last verified: 2014-05

Locations

US (1)