Skip to content

Standard Versus Flexible Tip Bougie for Videolaryngoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04973176
Enrollment
160
Registered
2021-07-22
Start date
2021-08-23
Completion date
2022-02-10
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Intratracheal

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

DEVICEStandard Bougie

Standard Bougie for endotracheal intubation

DEVICEFlexi-tip Bougie (P3 Medical Bristol,UK)

Flexi-tip Bougie for endotracheal intubation

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Modified Intubation Difficulty Scale Score (mIDS)average 1 minuteComposite 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

MeasureTime frameDescription
Time to Successful Tracheal Intubationless than two minutesTime from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.
Laryngoscopy Timeless than one minuteTime from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).
Overall First Attempt Success Rateaverage 1 minuteThis 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 Bougieaverage 1 minuteThis 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

ArmCount
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
Total160

Baseline characteristics

CharacteristicEndotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip BougieTotalEndotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants21 Participants11 Participants
Age, Categorical
Between 18 and 65 years
70 Participants139 Participants69 Participants
Age, Continuous55.2 year
STANDARD_DEVIATION 16.1
55.2 year
STANDARD_DEVIATION 16.1
55.3 year
STANDARD_DEVIATION 16.3
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United Kingdom
80 participants160 participants80 participants
Sex: Female, Male
Female
46 Participants86 Participants40 Participants
Sex: Female, Male
Male
34 Participants74 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 80
other
Total, other adverse events
0 / 800 / 80
serious
Total, serious adverse events
0 / 800 / 80

Outcome results

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)

Time frame: average 1 minute

ArmMeasureValue (MEDIAN)
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard BougieModified 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 BougieModified Intubation Difficulty Scale Score (mIDS)0 score on a scale range of 0 to 10 number
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

Time frame: average 1 minute

Population: this data was not collected and therefore not analysed

Secondary

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

ArmMeasureValue (MEAN)Dispersion
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard BougieLaryngoscopy Time5 secondsStandard Deviation 2
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip BougieLaryngoscopy Time4.6 secondsStandard Deviation 1.7
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

Time frame: average 1 minute

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard BougieOverall First Attempt Success Rate79 Participants
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip BougieOverall First Attempt Success Rate80 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard BougieTime to Successful Tracheal Intubation42.9 secondsStandard Deviation 9.1
Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip BougieTime to Successful Tracheal Intubation41.0 secondsStandard Deviation 6.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026