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VL vs DL in Inexperienced Users: a Pediatric Manikin Study

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ClinicalTrials.gov Identifier: NCT02991820
Recruitment Status : Completed
First Posted : December 14, 2016
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Videolaryngoscopes (VL) Direct Laryngoscopy (DL) Inexperienced Users Device: Miller Device: Macintosh Device: C-MAC Device: GlideScope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Official Title: Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study
Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Inexperienced users
Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Device: Miller
Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope

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

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

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

Experimental: Experienced users
Experienced users will include faculty pediatric anesthesiologists CRNAs.
Device: Miller
Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope

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

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

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




Primary Outcome Measures :
  1. Time to Endotracheal Intubation [ Time Frame: the same day (within seconds to minutes) ]
    The amount of time it took to successfully intubate the manikin using each device.


Secondary Outcome Measures :
  1. Successful Intubation Within 120 Seconds [ Time Frame: 2 minutes ]
    The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991820


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
Investigators
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Principal Investigator: Joseph Tobias, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Joseph D. Tobias, Nationwide Children's Hospital:
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Responsible Party: Joseph D. Tobias, Chairman, Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02991820    
Other Study ID Numbers: IRB16-00549
First Posted: December 14, 2016    Key Record Dates
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018
Last Verified: July 2018