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A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway.

A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03230422
Acronym
Kivi
Enrollment
80
Registered
2017-07-26
Start date
2017-07-24
Completion date
2017-09-27
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia

Keywords

infant, laryngoscopes, pediatrics

Brief summary

In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.

Detailed description

The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.

Interventions

DEVICEnormal airway

The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)

DEVICEdifficult airway

The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

residents, fellows and attending with different level of experience

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

\- anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway

Exclusion criteria

\- participants without experience in pediatric airway management

Design outcomes

Primary

MeasureTime frameDescription
Time to ventilation (seconds)Assessed intraoperatively at time of intubation (seconds)Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator

Secondary

MeasureTime frameDescription
First attempt success rate of tracheal intubation (in 40 seconds)Assessed intraoperatively at time of intubationAn attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.
Grades of Laryngeal View (Cormack&Lehane Class)Assessed intraoperatively at time of intubationCormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope
Use of ELMAssessed intraoperatively at time of intubationBURP or change the head/Shoulder position to optimised the glottic view will be recorded
Intubation Adjustments & Ease of UseAssessed intraoperatively following intubationAirway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026