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

NCT03230422 | Completed

• 1 other identifier: Johannes GU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Complication of Anesthesia

Keywords

infant, laryngoscopes, pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Assessed intraoperatively at time of intubation

• Grades of Laryngeal View (Cormack&Lehane Class)

  Assessed intraoperatively at time of intubation

• Use of ELM

  Assessed intraoperatively at time of intubation

• Intubation Adjustments & Ease of Use

  Assessed intraoperatively following intubation

Study Arms (2)

normal airway

EXPERIMENTAL

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)

Device: normal airway; Device: difficult airway

difficult airway

EXPERIMENTAL

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)

Device: normal airway; Device: difficult airway

Interventions

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; normal airway

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)

difficult airway; normal airway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- participants without experience in pediatric airway management

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

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

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related 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 age. Br J Anaesth. 2017 Jun 1;118(6):932-937. doi: 10.1093/bja/aex073.

  PMID: 28549081 RESULT

Study Officials

• Marc Kriege, MD

  University Medical Centre Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: residents, fellows and attending with different level of experience
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Marc Kriege, Dr. med. Nina Pirlich

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 26, 2017
• Study Start: July 24, 2017
• Primary Completion: July 31, 2017
• Study Completion: September 27, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)