Standard Versus Flexible Tip Bougie for Videolaryngoscopy

Intubation, Intratracheal Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973176
• Other study ID #: CM538321
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: Charles Pairaudeau, FRCA
• Phone: 02476964000
• Email: Charles.Pairaudeau2[@]uhcw.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Device:
• Standard Bougie
Standard Bougie for endotracheal intubation
• Flexi-tip Bougie (P3 Medical Bristol,UK)
Flexi-tip Bougie for endotracheal intubation

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified intubation difficulty scale score (mIDS)	Composite score of difficulty of tracheal intubation using the bougie devices	immediately after the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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