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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02295657
Other study ID # ETI/2014/43
Secondary ID
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


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
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