Clinical trial NCT04836338: GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations
Official title: Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Lead sponsor: Verathon
Sponsor class: INDUSTRY
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2021-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to intubate
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: First pass success rate
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Overall performance and clinical utility using a 5-point Likert Scale
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Secondary outcomes:
measure: Failed intubation attempt
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Intubation success on first attempt
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Other outcomes:
measure: Glottic view grade
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Time to visualize glottis
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Assessment of clinical utility and performance using a Lickert scale
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Observational description of features causing impediments
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Overall clinical usefulness
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
measure: Overall satisfaction of operator
timeFrame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Patrick Olomu, MD
role: PRINCIPAL_INVESTIGATOR
References: