University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
NCT Number: NCT04836338
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.
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Notify Me18 year and older
All sexes
Observational
Dallas, Texas, 75235, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
orotracheal intubation
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Time to intubate on each of 3 attempts per blade, on each manikin type.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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
e.g. - Participants will assign a number to the following statements:
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed 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.).
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Cumulative measure of intubation success on first attempt over 3 successive uses of the pediatric video laryngoscope, per blade, on each manikin type.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Glottic view grade on each of 3 attempts per blade, on each manikin type using the Cormack & Lehane grading scale:
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Time to visualize the glottis on each of 3 attempts per blade, on each manikin type.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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.
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
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.
Verathon
Industry
Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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