VL vs DL in Inexperienced Users: a Pediatric Manikin Study

Not Applicable

Completed

• Conditions: Videolaryngoscopes (VL); Inexperienced Users; Direct Laryngoscopy (DL)
• Interventions: Device: Miller; Device: Macintosh; Device: C-MAC; Device: GlideScope

• Registration Number: NCT02991820
• Lead Sponsor: Joseph D. Tobias

Brief Summary

This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.

Detailed Description

The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-14
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2018-02-06
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Results First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Faculty pediatric anesthesiologists
• CRNAs
• Trainees (SRNAs, residents, fellows, and medical students)
• Nurses from NCH

Exclusion Criteria

• If subjects are unwilling to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inexperienced users	C-MAC	Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Inexperienced users	Macintosh	Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Experienced users	GlideScope	Experienced users will include faculty pediatric anesthesiologists CRNAs.
Inexperienced users	Miller	Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Experienced users	Miller	Experienced users will include faculty pediatric anesthesiologists CRNAs.
Experienced users	Macintosh	Experienced users will include faculty pediatric anesthesiologists CRNAs.
Inexperienced users	GlideScope	Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Experienced users	C-MAC	Experienced users will include faculty pediatric anesthesiologists CRNAs.

Primary Outcome Measures

Name	Time	Method
Time to Endotracheal Intubation	the same day (within seconds to minutes)	The amount of time it took to successfully intubate the manikin using each device.

Secondary Outcome Measures

Name	Time	Method
Successful Intubation Within 120 Seconds	2 minutes	The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States