Pediatric Difficult Intubation

Cardiac Arrest Clinical Trial

— 3V-L DL  

Official title:

Can the Vividtrac Laryngoscope Rival the Miller Laryngoscope for Child Tracheal Intubation During Chest Compression in a Manikin? A Randomized Crossover Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295670
• Other study ID #: ETI/2014/51
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2014
• Last updated: November 18, 2014
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: International Institute of Rescue Research and Education
• Contact: Lukasz Szarpak
• Phone: +48500186225
• Email: lukasz.szarpak[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Give voluntary consent to participate in the study

• Paramedic student

Exclusion Criteria:

• Not meet the above criteria

• Wrist or Low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Intubation

Intervention

Device:
• Vividtrac
video-laryngoscopy
• MIL
direct-laryngoscopy

Locations

Country	Name	City	State
Poland	International Institute of Rescue Research and Education	Warsaw	Masovie

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubation	time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure	1 day	No
Secondary	Success of intubation	effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.; Visual Analog scale (VAS) score	1 day	No
Secondary	Cormack-Lehane grading	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)	1 day	No