Clinical Trials Directory

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CompletedNCT04973176

Standard Versus Flexible Tip Bougie for Videolaryngoscopy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEStandard BougieStandard Bougie for endotracheal intubation
DEVICEFlexi-tip Bougie (P3 Medical Bristol,UK)Flexi-tip Bougie for endotracheal intubation

Timeline

Start date
2021-08-23
Primary completion
2022-02-10
Completion
2022-02-10
First posted
2021-07-22
Last updated
2025-05-13
Results posted
2025-05-13

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04973176. Inclusion in this directory is not an endorsement.