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

NCT ID: NCT04836338

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-21

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants

Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations

orotracheal intubation

Intervention Type DEVICE

orotracheal intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

orotracheal intubation

orotracheal intubation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Verathon

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick Olomu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GSX 1401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Infant Glidescope® Learning Curve
NCT01793727 WITHDRAWN NA
Pediatric Intubation During CPR
NCT02289677 UNKNOWN NA