Duble Lumen Intubation

• Sponsor: Lazarski University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03624439
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult; Intubation; Difficult or Failed; Difficult Airway	Device: Standard double-lumen tube; Device: Double-Lumen Tube Vivasight-DL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 7, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. intubation time [1 day]

   from taking of the intubation device to successful intubation

Secondary Outcome Measures

1. time to visualize the glottis [1 day]

   time defined as the time from taking laryngoscope in hand until you obtain visualize the glottis

2. success of the first intubation trial [1 day]

   effectiveness of the first attempt of intubation by participants using four intubation devices

3. overall success rate [1 day]

   effectiveness measured during a maximum of three intubation attempts, confirmed by a single lung ventilation test

4. the degree of visibility of the glottis [1 day]

   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.

5. Cormack - Lehane grade [1 day]

   self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

6. ease of use [1 day]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Lazarski University	Warsaw	Masovian	Poland	02-662

Sponsors and Collaborators

• Lazarski University

Investigators

• Principal Investigator: Lukasz Szarpak, PhD, Lazarski University
• Principal Investigator: Jacek Smereka, Phd, Wroclaw Medical University

Study Documents (Full-Text)

None provided.

More Information

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, Zaśko 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.

• Responsible Party: Łukasz Szarpak, Associate Professor, Lazarski University
• ClinicalTrials.gov Identifier: NCT03624439
• Other Study ID Numbers: ETI_2018_DL1
• First Posted: Aug 10, 2018
• Last Update Posted: Jul 31, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Łukasz Szarpak, Associate Professor, Lazarski University: double-lumen tube; ETView; medical simulation; anesthesiologist; difficult airway

Study Results

No Results Posted as of Jul 31, 2019