Pediatric AnesthesiaNCT02841189
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children
A study testing King Vision video Laryngoscope in people with Pediatric Anesthesia and King Vision Video Laryngoscope Intubation, run by Indiana University at 1 site in United States.
Trial summary
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal… Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Pediatric Anesthesia, King Vision Video Laryngoscope Intubation
- What is being tested?
- King Vision video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between the ages of 1 month to 10 years with a normal preoperative airway examination
- Scheduled for a surgical procedure that requires tracheal intubation shall be included.
Who cannot join
- 1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
Official title: King Vision Video Laryngoscope aBlade System for Use in Children
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.
- Being tested
- King Vision video Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision video LaryngoscopeDevice
Also called Ambu
The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscope intubation | Other | The King Vision Video Laryngoscope will be used for intubation Receives: Device: King Vision video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Endotracheal Intubation
Ease of endotracheal intubation
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startDec 2014
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- King Systems Corporation
- Responsible party
- Principal investigator, Nicole Horn, Indiana University
- Investigators
- Nicole Horn, MD, Principal investigator, Riley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841189
- Sponsor's protocol ID
- 1409265337
- Status last verified
- May 2020
- First submitted
- 13 May 2016
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- King Vision Video Laryngoscope aBlade System for Use in Children
- ClinicalTrials.gov ID
- NCT02841189
- Acronym / sponsor ID
- 1409265337
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- King Systems Corporation
- Study start
- Dec 2014
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscope intubation | Other | Device: King Vision video LaryngoscopeThe King Vision Video Laryngoscope will be used for intubation |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All children between the ages of 1 month to 10 years with a normal preoperative airway examination
- Scheduled for a surgical procedure that requires tracheal intubation shall be included.
Key exclusion criteria (1 listed)
- 1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
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 |
|---|---|---|
| King Vision video LaryngoscopeAlso: AmbuThe King Vision video laryngoscope (Ambu) will be used for tracheal intubation. | Device | Video laryngoscope intubation |
Primary outcome
Ease of Endotracheal Intubation
Time frame: During intubation
Ease of endotracheal intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pediatric Anesthesia
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
RecruitingPhase 2
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Anesthesia, Pediatric Surgery
Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
Postoperative Pain, Caudal Anesthesia
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.
Nicole Horn, MD principal investigator
Riley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Vision video Laryngoscope in people with Pediatric Anesthesia and King Vision Video Laryngoscope Intubation, run by Indiana University 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 2 inclusion and 1 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 2 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ease of Endotracheal Intubation (time frame: During intubation). 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 2 Jun 2020; AzTrials last refreshed its copy on 4 Nov 2026.