Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04973176
Other study ID # CM538321
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT03301324 - Intubation Assist Clinical Study N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Not yet recruiting NCT04116333 - Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin N/A
Recruiting NCT02001285 - Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation N/A
Completed NCT02034643 - Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure N/A
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01227486 - Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient N/A
Withdrawn NCT01252173 - Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients N/A
Completed NCT04591769 - Tracheal Tube Cuff Shape and Pressure N/A
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A
Recruiting NCT03716713 - CeraShield™ Endotracheal Tube Feasibility Study N/A
Not yet recruiting NCT03938506 - The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
Not yet recruiting NCT01974505 - Learning Curve of Optiscope by Anesthesia Providers N/A
Completed NCT06107998 - Comparison of Different Methods for Determining Endotracheal Cuff Pressure N/A
Completed NCT02822846 - Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
Completed NCT03116373 - Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization N/A
Completed NCT02423317 - Comparison of Miller's Blade and Airtraq Laryngoscope in Children N/A
Completed NCT04863846 - Evidence-based Algorithm for the Expected Difficult Intubation
Not yet recruiting NCT04872881 - Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy Phase 4