Duble Lumen Intubation

Intubation; Difficult or Failed Clinical Trial

Official title:

Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624439
• Other study ID #: ETI_2018_DL1
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Lazarski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• anesthesiologist or a person in the course of specialization

• consent voluntary participation in the study

Exclusion Criteria:

• refusal to participate in the study

Related Conditions & MeSH terms

• Difficult Airway
• Intubation; Difficult or Failed
• Intubation;Difficult

Intervention

Device:
• Standard double-lumen tube
intubation using standard double-lumen tube with Macintosh laryngoscope
• Double-Lumen Tube Vivasight-DL
intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope

Locations

Country	Name	City	State
Poland	Faculty of Medicine, Lazarski University	Warsaw	Masovian

Sponsors (1)

Lead Sponsor	Collaborator
Lazarski University

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2. — 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	intubation time	from taking of the intubation device to successful intubation	1 day
Secondary	time to visualize the glottis	time defined as the time from taking laryngoscope in hand until you obtain visualize the glottis	1 day
Secondary	success of the first intubation trial	effectiveness of the first attempt of intubation by participants using four intubation devices	1 day
Secondary	overall success rate	effectiveness measured during a maximum of three intubation attempts, confirmed by a single lung ventilation test	1 day
Secondary	the degree of visibility of the glottis	The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.	1 day
Secondary	Cormack - Lehane grade	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)	1 day
Secondary	ease of use	To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 100 (extremely difficult).	1 day