Pediatric ALLNCT04836338
GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations
An observational study of Pediatric ALL, run by Verathon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- orotracheal intubation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2016to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Clinicians, anesthesia, and emergency medicine providers who perform pediatric intubations. Participants will be recruited from Children's Medical Center, Dallas.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric ALL
- Being tested
- orotracheal intubation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orotracheal intubationDevice
orotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Participants | Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations Receives: Device: orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubate
Time to intubate on each of 3 attempts per blade, on each manikin type.
Measured: 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.
Measured: 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 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
Measured: 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
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.).
Measured: 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.
Measured: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Jan 2016
- Primary completion9 Feb 2016
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verathon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Patrick Olomu, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836338
- Sponsor's protocol ID
- GSX 1401
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study
- ClinicalTrials.gov ID
- NCT04836338
- Acronym / sponsor ID
- GSX 1401
- Conditions
- Pediatric ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VerathonIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: orotracheal intubationAnesthesia and emergency medicine providers who perform pediatric orotracheal intubations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Clinicians, anesthesia, and emergency medicine providers who perform pediatric intubations. Participants will be recruited from Children's Medical Center, Dallas.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orotracheal intubationorotracheal intubation | Device | Participants |
Primary outcome
Time to intubate
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.
First pass success rate
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.
Overall performance and clinical utility using a 5-point Likert Scale
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 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
2 secondary outcomes
Failed intubation attempt
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Intubation success on first attempt
Time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Olomu, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Verathon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to intubate (time frame: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.