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Completed

NCT Number: NCT04973176

Standard Versus Flexible Tip Bougie for Videolaryngoscopy

This study aims to compare the flexible tip bougie with standard bougie for tracheal intubation using non channelled, acute angled video laryngoscope using modified intubation difficulty scale score as primary outcome.

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Key information

Conditions

Intubation, Intratracheal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

About this study

Videolaryngoscopes are devices which aid successful intubation of the trachea. Unlike standard (direct) laryngoscopes, they include a camera at the tip of the blade and display unit to provide an indirect view of the vocal cords (glottis). They are now routinely used for both standard and anticipated difficult tracheal intubation, and are recommended for difficult intubation in UK national guidelines.

Some videolaryngsocopes have a channel as a guide to help with placement of a tracheal tube and some are without a channel. The non-channelled videolaryngoscopes with acute-angled blades require a bougie or stylet to facilitate the passage of a tracheal tube through the glottis into the trachea.

One problem commonly encountered when using a standard bougie, is the tip of the bougie abutting on the anterior part of glottis and entrance to the windpipe (trachea) and not advancing further into the trachea. This is known as anterior impingement. This can increase the likelihood of repeated intubation attempts, failed intubation and airway trauma. C-Mac is a commonly used non-channelled videolaryngoscope and has been shown to have high first attempt success rate as compared to other videolaryngoscopes, however, the acute angled D-blade requires a bougie to facilitate tracheal intubation.

The recently introduced flexible tip bougie is likely to overcome the problem of anterior impingement, due to the ability to flex the tip in the posterior direction once the tip enters the glottis. Comparing the efficacy of these devices could help inform anaesthetists' decisions in the future when faced with a potentially difficult airway.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.

Exclusion criteria

  • Patients who are do not want to take part or do not give consent
  • Patients below 18 years of age
  • Patient physical status of ASA 4 and 5,
  • Patients deemed to require awake intubation

Treatment and study plan

Standard Bougie

Device

Standard Bougie for endotracheal intubation

Flexi-tip Bougie (P3 Medical Bristol,UK)

Device

Flexi-tip Bougie for endotracheal intubation

Primary outcomes

  1. Modified Intubation Difficulty Scale Score (mIDS)

    Time frame: average 1 minute

    Composite score of difficulty of tracheal intubation using the bougie devices minimum score is zero, maximum possible score is 10, higher values represent worse outcome. Total score is sum of sub scales, values are numbers Total 6 sub scale from N1 to N6 ( N1: 0-2, N2: 0-1, N3:0-5, N4: 0-1, N5 0-1, N6 0-1, so total mIDS score is sum of N1 to N 6 sub scales)

Secondary outcomes

  1. Time to Successful Tracheal Intubation

    Time frame: less than two minutes

    Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.

  2. Laryngoscopy Time

    Time frame: less than one minute

    Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).

  3. Overall First Attempt Success Rate

    Time frame: average 1 minute

    This is the percentage of patients being successfully intubated at the first attempt. This will be compared for two bougies

  4. Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie

    Time frame: average 1 minute

    This is scored between 0 to 10, 0 being easy to use and 10 being extremely difficult to use

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

Standard Versus Flexible Tip Bougie for Videolaryngoscopy: A Randomised Comparison Between Standard and Flexible Tip Bougie (Tracheal Tube Introducers) for Tracheal Intubation Using Non Channelled Videolaryngoscope

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
May 13, 2025

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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