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NCT02741921 Clinical Trial

Conventional Double-lumen Tube vs VivaSight DL

Endotracheal Intubation Clinical Trial

Official title:
Ability of Anesthesiologist to Placid a Double-lumen Tube. A Randomized Crossover Cadaver Study Comparing VivaSight DL and Conventional Double-lumen Tube

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02741921
Other study ID # 02/04/2016
Secondary ID
Status Completed
Phase N/A
First received April 13, 2016
Last updated April 15, 2016
Start date November 2015
Est. completion date March 2016

Study information
Verified date April 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 investigators sought to compare the time to intubation and success rate of the endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult cadaver model in normal and difficult airway conditions.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- fresh adult cadavers

Exclusion Criteria:

- cadavers with face injures

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• VivaSight DL
intubation using VivaSight DL tube
• conventional double-lumen tube
intubation using conventional double-lumen 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 (2)

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

Szarpak L, Kurowski A, Zasko P, Karczewska K, Czyzewski L, Bogdanski L, Adamczyk P, Truszewski Z. Double-lumen tube tracheal intubation in a manikin model using the VivaSight Double Lumen: a randomized controlled comparison with the Macintosh laryngoscope. Am J Emerg Med. 2016 Jan;34(1):103-4. doi: 10.1016/j.ajem.2015.10.018. Epub 2015 Oct 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time required for endotracheal intubation time from pick up the tube to first ventilation 1 day No
Secondary Time required for visual confirmation of double lumen tube position position Time required for visual confirmation of double lumen tube position position 1 day No
Secondary success rate of intubation attempt success rate of first intubation attempt 1 day No
Secondary Ease of intubation To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). 1 day No
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