Standard Versus Flexible Tip Bougie for Videolaryngoscopy

NCT ID: NCT04973176

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2022-02-10

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.

Conditions

Intubation, Intratracheal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Standard Bougie

Intervention Type: DEVICE

Standard Bougie for endotracheal intubation

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

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

Group Type: ACTIVE_COMPARATOR

Flexi-tip Bougie (P3 Medical Bristol,UK)

Intervention Type: DEVICE

Flexi-tip Bougie for endotracheal intubation

Interventions

Standard Bougie

Standard Bougie for endotracheal intubation

Intervention Type: DEVICE

Flexi-tip Bougie (P3 Medical Bristol,UK)

Flexi-tip Bougie for endotracheal intubation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyprian Mendonca, Phd, MD FRCA

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Coventry & Warwickshire NHS Trust

Locations

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CM538321

Identifier Type: -

Identifier Source: org_study_id