Standard Versus Flexible Tip Bougie for Videolaryngoscopy

Not Applicable

Completed

Conditions: Intubation, Intratracheal

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

Registration Number: NCT04973176

Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie	Flexi-tip Bougie (P3 Medical Bristol,UK)	Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK)
Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie	Standard Bougie	Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter )

Primary Outcome Measures

Name	Time	Method
Modified Intubation Difficulty Scale Score (mIDS)	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 Outcome Measures

Name	Time	Method
Time to Successful Tracheal Intubation	less than two minutes	Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.
Laryngoscopy Time	less than one minute	Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).
Overall First Attempt Success Rate	average 1 minute	This is the percentage of patients being successfully intubated at the first attempt. This will be compared for two bougies
Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie	average 1 minute	This is scored between 0 to 10, 0 being easy to use and 10 being extremely difficult to use