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

NCT04836338 | Completed FDA Device

• 1 other identifier: GSX 1401
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL

Outcome Measures

Primary Outcomes (3)

• 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 1. = strongly disagree 2. = disagree 3. = neutral 4. = agree 5. = strongly agree e.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 manikin * The pediatric style was easy to insert into the mouth of the when used with the difficult neonate manikin * The 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 Outcomes (2)

• Failed intubation attempt

  120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

• Intubation success on first attempt

  120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

Other Outcomes (6)

• Glottic view grade

  120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

• Time to visualize glottis

  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

  120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.

Study Arms (1)

Participants

Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations

Device: orotracheal intubation

Interventions

orotracheal intubation DEVICE

orotracheal intubation

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verathon: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Patrick Olomu, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: April 8, 2021
• Study Start: January 21, 2016
• Primary Completion: February 9, 2016
• Study Completion: October 1, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)