Standard Versus Flexible Tip Bougie for Videolaryngoscopy

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Intubation, Intratracheal

Treatments: Device: Flexi-tip Bougie (P3 Medical Bristol,UK); Device: Standard Bougie

Study type: Interventional

Funder types: Other

Identifiers

NCT04973176

CM538321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie

Active Comparator group

Description:

Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter )

Treatment:

Device: Standard Bougie

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie

Active Comparator group

Description:

Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK)

Treatment:

Device: Flexi-tip Bougie (P3 Medical Bristol,UK)