VL vs DL in Inexperienced Users: a Pediatric Manikin Study

NCT ID: NCT02991820

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-05-31

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.

Conditions

Videolaryngoscopes (VL); Direct Laryngoscopy (DL); Inexperienced Users

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER

Study Groups

Inexperienced users

Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.

Group Type: EXPERIMENTAL

Miller

Intervention Type: DEVICE

Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope

Macintosh

Intervention Type: DEVICE

Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope

C-MAC

Intervention Type: DEVICE

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope

GlideScope

Intervention Type: DEVICE

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope

Experienced users

Experienced users will include faculty pediatric anesthesiologists CRNAs.

Group Type: EXPERIMENTAL

Miller

Intervention Type: DEVICE

Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope

Macintosh

Intervention Type: DEVICE

Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope

C-MAC

Intervention Type: DEVICE

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope

GlideScope

Intervention Type: DEVICE

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope

Interventions

Miller

Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope

Intervention Type: DEVICE

Macintosh

Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope

Intervention Type: DEVICE

C-MAC

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope

Intervention Type: DEVICE

GlideScope

Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• If subjects are unwilling to participate.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Joseph D. Tobias

OTHER

Sponsor Role: lead

Responsible Party

Joseph D. Tobias

Chairman, Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB16-00549

Identifier Type: -

Identifier Source: org_study_id