GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations

Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study

The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL
• Intervention / Treatment: Device: orotracheal intubation

Detailed Description

The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin.

Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical & functional usefulness in airways with predictors of difficult intubation.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinicians, anesthesia, and emergency medicine providers who perform pediatric intubations. Participants will be recruited from Children's Medical Center, Dallas.

Description

Inclusion Criteria:

• Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations
• Able to give voluntary consent to participate in the study
• Are experienced with orotracheal intubation (> 50 times) using direct laryngoscopy or video laryngoscopy

Exclusion Criteria:

• Volunteers who are < 18 years of age
• Volunteers unable to read or understand English
• Unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. Are not experienced with pediatric orotracheal intubations

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations	Device: orotracheal intubation; orotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubate	Time to intubate on each of 3 attempts per blade, on each manikin type.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
First pass success rate	First pass success rate on each of 3 attempts per blade, on each manikin type. First pass success (FPS) is defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the video laryngoscope from the patient's mouth.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Overall performance and clinical utility using a 5-point Likert Scale	Overall performance and clinical utility of single-use pediatric stylet; Using a 5-point LIKERT SCALE, participants will grade the following statements with regards to the use of the single-use pediatric stylet; = strongly disagree; = disagree; = neutral; = agree; = strongly agreee.g. - Participants will assign a number to the following statements:The pediatric style was easy to insert into the mouth of the when used with normal neonate manikinThe pediatric style was easy to insert into the mouth of the when used with the difficult neonate manikinThe pediatric style was easy to insert into the mouth of the when used with normal pediatric manikin	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failed intubation attempt	The time taken for an intubation attempt that ultimately fails proper tube placement, or exceeds the allowed time for intubation under this protocol. Failed intubation attempt is defined as an attempt to intubate that does not result in tube placement, that is longer than 120 seconds, or results in a wrong placement of endotracheal tube (For example: Esophageal intubation, etc.).	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Intubation success on first attempt	Cumulative measure of intubation success on first attempt over 3 successive uses of the pediatric video laryngoscope, per blade, on each manikin type.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glottic view grade	Glottic view grade on each of 3 attempts per blade, on each manikin type using the Cormack & Lehane grading scale: Grade 1 = Full view of vocal cords; Grade 2a = Partial view of vocal cords; Grade 2b = Only arytenoids/posterior part of vocal cords; Grade 3 = Only epiglottis visible, no view of glottis or arytenoids; Grade 4 = Neither glottis nor epiglottis visible	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Time to visualize glottis	Time to visualize the glottis on each of 3 attempts per blade, on each manikin type.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Assessment of clinical utility and performance using a Lickert scale	Assessment of the clinical utility and performance of the pediatric blades using a 5-point Lickert scale, where 1 = strongly disagree, 2 = disagree, 3= neutral, 4 = agree, 5 = strongly agree.; Ease of the pediatric video laryngoscope blade insertion when attempting to insert the pediatric video laryngoscope blade into manikin's mouth for each blade type and manikin type.; Ease of tracheal intubation when attempting to pass a tracheal tube below manikin's vocal cords using each of the pediatric video laryngoscope blades on each manikin type.; Assessment of the comfort of each blade handle during neonate/pediatric intubations.; Assessment of the blade and cable connection during neonate/pediatric intubation with each blade type.; Assessment of potential cable interference during neonate/pediatric intubation with each blade type.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Observational description of features causing impediments	Participant self-reported observational description of potential features causing intubation impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid). Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using each of the pediatric video laryngoscope blades.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Overall clinical usefulness	Recorded as excellent, good, fair, or inadequate by the study subject when using the pediatric video laryngoscope and stylet to place a tracheal tube below a patient's vocal cords.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Overall satisfaction of operator	Recorded as excellent, good, fair, or inadequate by the study subject when using each of the pediatric video laryngoscope blades and stylet to place a tracheal tube below manikin's vocal cords.	120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

Collaborators and Investigators

• Sponsor: Verathon
• Collaborators: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Patrick Olomu, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Actual): February 9, 2016
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GSX 1401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes