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Completed

NCT Number: NCT03230422

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

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

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Key information

Conditions

Airway Complication of Anesthesia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal airway

Device

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)

difficult airway

Device

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)

Primary outcomes

  1. Time to ventilation (seconds)

    Time frame: 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 outcomes

  1. First attempt success rate of tracheal intubation (in 40 seconds)

    Time frame: Assessed intraoperatively at time of intubation

    An 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.

  2. Grades of Laryngeal View (Cormack&Lehane Class)

    Time frame: Assessed intraoperatively at time of intubation

    Cormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope

  3. Use of ELM

    Time frame: Assessed intraoperatively at time of intubation

    BURP or change the head/Shoulder position to optimised the glottic view will be recorded

  4. Intubation Adjustments & Ease of Use

    Time frame: Assessed intraoperatively following intubation

    Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: Kivi

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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