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

Airway Complication of Anesthesia Clinical Trial

— Kivi  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230422
• Other study ID #: Johannes GU
• Status: Completed
• Phase: N/A
• First received: July 23, 2017
• Last updated: September 28, 2017
• Start date: July 24, 2017
• Est. completion date: September 27, 2017

Study information

• Verified date: September 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 27, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Device:
• normal 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)
• difficult 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)

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Albers B, Bienia S, De Oliveira GS. Randomized equivalence trial of the King Vision aBlade videolaryngoscope with the Miller direct laryngoscope for routine tracheal intubation in children <2 yr of a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ventilation (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	Assessed intraoperatively at time of intubation (seconds)
Secondary	First attempt success rate of tracheal intubation (in 40 seconds)	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.	Assessed intraoperatively at time of intubation
Secondary	Grades of Laryngeal View (Cormack&Lehane Class)	Cormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope	Assessed intraoperatively at time of intubation
Secondary	Use of ELM	BURP or change the head/Shoulder position to optimised the glottic view will be recorded	Assessed intraoperatively at time of intubation
Secondary	Intubation Adjustments & Ease of Use	Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.	Assessed intraoperatively following intubation