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NCT02804451 Clinical Trial

Intubation During Cardiopulmonary Resuscitation

Endotracheal Intubation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02804451
Other study ID # 03/02/2016
Secondary ID
Status Completed
Phase N/A
First received June 11, 2016
Last updated June 14, 2016
Start date December 2015
Est. completion date March 2016

Study information
Verified date June 2016
Source Medical University of Warsaw
Contact n/a
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 the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- had not received any training in endotracheal intubation with videolaryngoscopy before the study,

- had nursing specialization in anaesthesiology or emergency medicine,

- presented with no wrist or low back diseases or pregnancy.

Exclusion Criteria:

- not meet the above criteria.

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Macintosh laryngoscope
intubation with standard macintosh larygoscope; gold standard
• TruView EVO2 laryngoscope
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
• TruView EVO2 PCD laryngoscope
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
• ETView SL
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube

Locations
Country Name City State
Poland Medical University of Warsaw, Department of Emergency Medicine Warsaw Masovia

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850. Erratum in: Medicine (Baltimore). 2015 Jun;94(25):1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary time to the first ventilation attempt 1 day No
Secondary time to visualize the larynx 1 day No
Secondary time to introduce the endotracheal tube through the vocal cords 1 day No
Secondary success rate first intubation attempt success rate 1 day No
Secondary degree of larynx visibility analysed based on a Cormack-Lehane scale 1 day No
Secondary ease of intubation technique 10-point visual analogue scale (VAS) was used, where 1 indicated an extremely simple procedure, while 10 - an extremely difficult one 1 day No
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