Standard Versus Flexible Tip Bougie for Videolaryngoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intubation, Intratracheal

Intervention / Treatment
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* Device: Standard Bougie
* Device: Flexi-tip Bougie (P3 Medical Bristol,UK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie<br>Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) | Device: Standard Bougie<br>* Standard Bougie for endotracheal intubation<br>|
| Active Comparator: Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie<br>Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) | Device: Flexi-tip Bougie (P3 Medical Bristol,UK)<br>* Flexi-tip Bougie for endotracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified intubation difficulty scale score (mIDS) | Composite score of difficulty of tracheal intubation using the bougie devices | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful tracheal intubation | Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained. | less than two minutes | 
| Laryngoscopy time | Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords). | less than one minute | 
| Overall first attempt success rate | This is the percentage of patients being successfully intubated at the first attempt. This will be compared for two bougies | immediately after the intervention | 
| Anaesthetist's visual analogue score for ease of use of the bougie | This is scored between 0 to 10, 0 being easy to use and 10 being extremely difficult to use | immediately after the intervention |