Intubation, Intratracheal
Conditions
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.
Interventions
Standard Bougie for endotracheal intubation
Flexi-tip Bougie for endotracheal intubation
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Intubation Difficulty Scale Score (mIDS) | average 1 minute | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Tracheal Intubation | less than two minutes | Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained. |
| Laryngoscopy Time | less than one minute | Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords). |
| Overall First Attempt Success Rate | average 1 minute | This is the percentage of patients being successfully intubated at the first attempt. This will be compared for two bougies |
| Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie | average 1 minute | This is scored between 0 to 10, 0 being easy to use and 10 being extremely difficult to use |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 80 |
| 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 | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Total | Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 21 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 139 Participants | 69 Participants |
| Age, Continuous | 55.2 year STANDARD_DEVIATION 16.1 | 55.2 year STANDARD_DEVIATION 16.1 | 55.3 year STANDARD_DEVIATION 16.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 80 participants | 160 participants | 80 participants |
| Sex: Female, Male Female | 46 Participants | 86 Participants | 40 Participants |
| Sex: Female, Male Male | 34 Participants | 74 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
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)
Time frame: average 1 minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie | Modified Intubation Difficulty Scale Score (mIDS) | 1 score on a scale range of 0 to 10 number |
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Modified Intubation Difficulty Scale Score (mIDS) | 0 score on a scale range of 0 to 10 number |
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
Time frame: average 1 minute
Population: this data was not collected and therefore not analysed
Laryngoscopy Time
Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).
Time frame: less than one minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie | Laryngoscopy Time | 5 seconds | Standard Deviation 2 |
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Laryngoscopy Time | 4.6 seconds | Standard Deviation 1.7 |
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
Time frame: average 1 minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie | Overall First Attempt Success Rate | 79 Participants |
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Overall First Attempt Success Rate | 80 Participants |
Time to Successful Tracheal Intubation
Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.
Time frame: less than two minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie | Time to Successful Tracheal Intubation | 42.9 seconds | Standard Deviation 9.1 |
| Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Time to Successful Tracheal Intubation | 41.0 seconds | Standard Deviation 6.1 |