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Completed

NCT Number: NCT03733158

Flexible Tip Bougie Catheter Intubation

We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.

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Key information

Conditions

Emergency Medicine Cardiopulmonary Arrest Cardiovascular Diseases Endotracheal Intubation Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lazarski University

Warsaw, Masovia, 02-662, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • physicians
  • give voluntary consent to participate in the study
  • none experience in videolaryngoscopy
  • less than 1 year experience in medicine

Exclusion criteria

  • not meet the above criteria
  • wrist or low back diseases

Treatment and study plan

the standard Bougie stylet for difficult intubation

Device

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Device

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Primary outcomes

  1. time to intubation

    Time frame: 1 day

    time from pick up device to the final placement tube in trachea

Secondary outcomes

  1. success of intubation

    Time frame: 1 day

    A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform

  2. Number of optimalization maneuvers

    Time frame: 1 day

    the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.

  3. Ease of use

    Time frame: 1 day

    self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy

  4. Dental compression

    Time frame: 1 day

    An independent observer scored the severity of dental compressions, which was calculated based on the number of audible teeth clicks (0; 1; ≥2) with the Laerdal airway trainer, and based on a grading of pressure of the teeth (none = 0; mild = 1; moderate/serve ≥2) on the Simman®3G simulator. At the end of each scenario, each participant scored the ease of use of each intubation method on a visual analogue scale (VAS; from 0=Extremely Easy to 100=Extremely Difficult).

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Registry information

Official study title

Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2018
Registry last updated
Jun 19, 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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