Pediatric Intubation During Resuscitation

Intubation Clinical Trial

— PIDR  

Official title:

A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277405
• Other study ID #: ETI/2014/04
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2014
• Last updated: October 27, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: International Institute of Rescue Research and Education
• Contact: Lukasz Czyzewski
• Phone: +48696457655
• Email: czyzewski_lukasz[@]wp.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.

Description:

Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2014
• Est. primary completion date: November 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

• minimum 1 year of work experience in emergency medicine

• experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

• not meet the above criteria

• wrist or low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation
• Resuscitation

Intervention

Device:
• Shikani Optical Stylet
Optical intubation
• Endoeye Flexible Intubation (LF-V)
endoscopy intubation

Locations

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

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 month	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.	1 month	No
Secondary	VAS score	participants were asked which method they would prefer in a real-life resuscitation.	1 month	No