Double Lumen Tube Intubation

Cardiac Arrest Clinical Trial

— DLETI  

Official title:

Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295657
• Other study ID #: ETI/2014/43
• 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: Andrzej Kurowski
• Phone: +48500186225
• Email: andrzejkurowski987[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• 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

• minimum 1 year of work experience in emergency medicine

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

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
• Endotracheal Intubation
• Heart Arrest

Intervention

Device:
• standard double-lumen tube
intubation using standard double-lumen tube
• VivaSight Double Lumen Tube
intubation using VivaSight Double Lumen Tube

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	Success of intubation	effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants	1 day	No
Secondary	Intubation time	time in seconds required for a successful intubation attempt	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
Secondary	Preferred ETI device	participants were asked which method of ETI they would prefer in a real-life.	1day	No