Clinical trial NCT04973176: Standard Versus Flexible Tip Bougie for Videolaryngoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Intubation Difficulty Scale Score (mIDS)
timeFrame: average 1 minute
Secondary outcomes:
measure: Time to Successful Tracheal Intubation
timeFrame: less than two minutes
measure: Laryngoscopy Time
timeFrame: less than one minute
measure: Overall First Attempt Success Rate
timeFrame: average 1 minute
measure: Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie
timeFrame: average 1 minute
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
state: West Midlands
Study officials:
affiliation: University Hospitals Coventry & Warwickshire NHS Trust
name: Cyprian Mendonca, Phd, MD FRCA
role: PRINCIPAL_INVESTIGATOR
References: