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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie | Active Comparator | Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) |
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| Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Active Comparator | Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Bougie | Device | Standard Bougie for endotracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Intubation Difficulty Scale Score (mIDS) | 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) | average 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Laryngoscopy Time |
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Inclusion Criteria:
- Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyprian Mendonca, Phd, MD FRCA | University Hospitals Coventry & Warwickshire NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | West Midlands | CV2 2DX | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 ) Standard Bougie: Standard Bougie for endotracheal intubation |
| FG001 | 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) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 ) Standard Bougie: Standard Bougie for endotracheal intubation |
| BG001 | Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Intubation Difficulty Scale Score (mIDS) | 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) | Posted | Median | Inter-Quartile Range | score on a scale range of 0 to 10 number | average 1 minute |
|
24 hours
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 ) Standard Bougie: Standard Bougie for endotracheal intubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cyprian Mendonnca | University Hospitals Coventry and Warwickshire NHS Trust | 02476964000 | 25784 | cyprian.mendonca@uhcw.nhs.uk |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2021 | May 30, 2024 | Prot_000.pdf |
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| Flexi-tip Bougie (P3 Medical Bristol,UK) | Device | Flexi-tip Bougie for endotracheal intubation |
|
Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).
| less than one minute |
| 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 | average 1 minute |
| 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 | average 1 minute |
Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation |
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| Secondary | Time to Successful Tracheal Intubation | Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained. | Posted | Mean | Standard Deviation | seconds | less than two minutes |
|
|
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| Secondary | Laryngoscopy Time | Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords). | Posted | Mean | Standard Deviation | seconds | 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 | Posted | Count of Participants | Participants | average 1 minute |
|
|
|
| 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 | this data was not collected and therefore not analysed | Posted | average 1 minute |
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation | 0 | 80 | 0 | 80 | 0 | 80 |
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