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

Not Applicable

Completed

• Conditions: Airway Complication of Anesthesia
• Interventions: Device: normal airway; Device: difficult airway

• Registration Number: NCT03230422
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2017-07-23
• Study Start: 2017-07-24
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Primary Completion: 2017-07-31
• Status Verified: 2017-09
• Study Completion: 2017-09-27
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
difficult airway	difficult airway	Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
normal airway	normal airway	Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
normal airway	difficult airway	Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
difficult airway	normal airway	Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Grades of Laryngeal View (Cormack&Lehane Class)	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
First attempt success rate of tracheal intubation (in 40 seconds)	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.
Use of ELM	Assessed intraoperatively at time of intubation	BURP or change the head/Shoulder position to optimised the glottic view will be recorded
Intubation Adjustments & Ease of Use	Assessed intraoperatively following intubation	Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany