Duble Lumen Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed; Difficult Airway; Intubation;Difficult
• Intervention / Treatment: Device: Standard double-lumen tube; Device: Double-Lumen Tube Vivasight-DL

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Masovian
    • Warsaw, Masovian, Poland, 02-662
      • Faculty of Medicine, Lazarski University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal airway; normal airway. the language has not been inflated. the instructor assessed the difficulty of intubation based on the Cormack - Lehane scale to the first degree	Device: Standard double-lumen tube; intubation using standard double-lumen tube with Macintosh laryngoscope; Device: Double-Lumen Tube Vivasight-DL; intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope
Experimental: Difficult airway; dofficult airway. Difficult airways were obtained by means of language inflation using a simulator control panel, so as to obtain the degree of intubation difficulty assessed by an independent anesthesiologist to the third degree according to the Cormack-Lehane scale	Device: Standard double-lumen tube; intubation using standard double-lumen tube with Macintosh laryngoscope; Device: Double-Lumen Tube Vivasight-DL; intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	from taking of the intubation device to successful intubation	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to visualize the glottis	time defined as the time from taking laryngoscope in hand until you obtain visualize the glottis	1 day
success of the first intubation trial	effectiveness of the first attempt of intubation by participants using four intubation devices	1 day
overall success rate	effectiveness measured during a maximum of three intubation attempts, confirmed by a single lung ventilation test	1 day
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
Cormack - Lehane grade	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)	1 day
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

Collaborators and Investigators

• Sponsor: Lazarski University
• Investigators: Principal Investigator: Jacek Smereka, PhD, Wroclaw Medical University

Publications and helpful links

General Publications

• 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.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: double-lumen tube; ETView; medical simulation; anesthesiologist; difficult airway
• Other Study ID Numbers: ETI_2018_DL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The datasets used and/or analyzed during the current study available from the corresponding author on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No