VL vs DL in Inexperienced Users: a Pediatric Manikin Study
Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
July 18, 2018
CompletedJuly 18, 2018
July 1, 2018
11 months
December 6, 2016
February 6, 2018
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Endotracheal Intubation
The amount of time it took to successfully intubate the manikin using each device.
the same day (within seconds to minutes)
Secondary Outcomes (1)
Successful Intubation Within 120 Seconds
2 minutes
Study Arms (2)
Inexperienced users
EXPERIMENTALInexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Experienced users
EXPERIMENTALExperienced users will include faculty pediatric anesthesiologists CRNAs.
Interventions
Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope
Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
Eligibility Criteria
You may qualify if:
- Faculty pediatric anesthesiologists
- CRNAs
- Trainees (SRNAs, residents, fellows, and medical students)
- Nurses from NCH
You may not qualify if:
- If subjects are unwilling to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Results Point of Contact
- Title
- Joseph D. Tobias, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Tobias, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman, Professor of Anesthesiology
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 14, 2016
Study Start
June 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
July 18, 2018
Results First Posted
July 18, 2018
Record last verified: 2018-07