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NCT02295631 Clinical Trial

ETI During Spinal Trauma

Cardiac Arrest Clinical Trial

Official title:
A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02295631
Other study ID # ETI/2014/42
Secondary ID
Status Recruiting
Phase N/A
First received November 18, 2014
Last updated November 26, 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 tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
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 tracheal tube
ETI with standard tracheal tube and Macintosh laryngoscope
• ETView VivaSight SL
ETI with ETView VivaSight SL

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 resuscitation. 1day No
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