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Completed

NCT Number: NCT02640196

Videolaryngoscopes for Double Lumen Tube Intubations in Simulated Easy and Difficult Airway

The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.

Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.

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Key information

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dammam University KFHU

Khobar, EP, 31952, Saudi Arabia

About this study

Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.

The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.

To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.

Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Staff anesthesiologists
  • Signed consent
  • Limited experience in using videolaryngoscopes for inserting double lumen tubes

Exclusion criteria

  • Decline to sign the consent
  • Non receiving the prior training demonstration
  • Non practicing once with each device tested on each simulator scenario

Treatment and study plan

Macintosh

Device

The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator

Glidescope

Device

The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator

Airtraq

Device

The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator

King Vision

Device

The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator

Primary outcomes

  1. Time to achieve successful double lumen tube intubation

    Time frame: for 6 min after using each device

    defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).

Secondary outcomes

  1. Best view during laryngoscopy using the classification described by Cormack and Lehane

    Time frame: for 1 min after laryngoscopy

    using the classification described by Cormack and Lehane

  2. Difficulty of intubation using a Visual Analog Scale (VAS)

    Time frame: for 6 min after using each device

    The difficulty of intubation was evaluated using a visual analog scale (VAS) (ranging from 0: extremely easy, to 100: extremely difficult) expressed by the anesthesiologists after the DLT intubation

  3. Number of first-pass success

    Time frame: for 3 min after using each device

    first-pass success calculated as number of first-attempt successes/number of patients with an intubation attempt

  4. Number of the required optimisation manoeuvers

    Time frame: for 6 min after using each device

    When the anaesthesiologists encountered difficulty in visualising vocal cords or placing the tube, they were allowed to use any manoeuver they would normally use to navigate the tube into the trachea including readjustment of the blade or tube or to ask the supervising investigator to help solve the problem, and gave suggestions or instructions

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2015
Registry last updated
Dec 28, 2015

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.