Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq

NCT02290249 | Completed Phase 4

• 1 other identifier: KOU KAEK 2014/145
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal. Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.

Conditions

Intubation; Difficult; Edema of the Tongue

Outcome Measures

Primary Outcomes (1)

• intubation success rates

  We recorded the first and total intubation success rates of the intubation with one of these devices

  5 minutes

Secondary Outcomes (3)

• intubation time

  5 minutes

• Esophageal intubation

  5 minutes

• need of optimisation maneuvers

  5 minutes

Study Arms (3)

normal airway

ACTIVE COMPARATOR

İntubation with glidescope or airtraq in normal airway

Device: Glidescope; Device: Airtraq

tongue edema

ACTIVE COMPARATOR

intubation with glidescope or airtraq in tongue edema simulation

Device: Glidescope; Device: Airtraq

face-to-face

ACTIVE COMPARATOR

intubation with glidescope or airtraq in face-to-face intubation

Device: Glidescope; Device: Airtraq

Interventions

Glidescope DEVICE

Manikin was intubated by different novice personal with glidescope videolaryngoscope

face-to-face; normal airway; tongue edema

Airtraq DEVICE

Pediatric manikin was intubated by novice personal with airtraq

face-to-face; normal airway; tongue edema

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• medical students at their third year,
• novice personnel

You may not qualify if:

• anesthesists,
• anesthesia residents,
• skilled investigators of tracheal intubation

Sponsors & Collaborators

• Kocaeli University: lead

Study Officials

• Zehra I ARSLAN, Doctor

  Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03