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Completed

NCT Number: NCT03624439

Duble Lumen Intubation

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.

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Key information

Conditions

Intubation;Difficult Difficult Airway Intubation; Difficult or Failed

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, 02-662, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard double-lumen tube

Device

intubation using standard double-lumen tube with Macintosh laryngoscope

Double-Lumen Tube Vivasight-DL

Device

intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope

Primary outcomes

  1. intubation time

    Time frame: 1 day

    from taking of the intubation device to successful intubation

Secondary outcomes

  1. time to visualize the glottis

    Time frame: 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

    Time frame: 1 day

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

  3. overall success rate

    Time frame: 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

    Time frame: 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

    Time frame: 1 day

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

  6. ease of use

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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