Intubation, IntratrachealNCT04973176
Standard Versus Flexible Tip Bougie for Videolaryngoscopy
A study testing Standard Bougie and Flexi-tip Bougie (P3 Medical Bristol,UK) in people with Intubation, Intratracheal, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Standard Bougie and Flexi-tip Bougie (P3 Medical Bristol,UK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Official title: 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
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.
Read the 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
- Being tested
- Standard Bougie, Flexi-tip Bougie (P3 Medical Bristol,UK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard BougieDevice
Standard Bougie for endotracheal intubation
Flexi-tip Bougie (P3 Medical Bristol,UK)Device
Flexi-tip Bougie for endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: Device: Standard Bougie |
| 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) Receives: Device: Flexi-tip Bougie (P3 Medical Bristol,UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: average 1 minute
Secondary outcomes (4)
Time to Successful Tracheal Intubation
Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.
Measured: less than two minutes
Laryngoscopy Time
Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).
Measured: 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
Measured: 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
Measured: average 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start23 Aug 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyprian Mendonca, Phd, MD FRCA, Principal investigator, University Hospitals Coventry & Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973176
- Sponsor's protocol ID
- CM538321
- Status last verified
- Apr 2025
- First submitted
- 9 Jul 2021
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04973176
- Acronym / sponsor ID
- CM538321
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie | Active comparator | Device: Standard BougiePatients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) |
| Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie | Active comparator | Device: Flexi-tip Bougie (P3 Medical Bristol,UK)Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard BougieStandard Bougie for endotracheal intubation | Device | Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie |
| Flexi-tip Bougie (P3 Medical Bristol,UK)Flexi-tip Bougie for endotracheal intubation | Device | Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie |
Primary outcome
Modified Intubation Difficulty Scale Score (mIDS)
Time frame: 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)
4 secondary outcomes
Time to Successful Tracheal Intubation
Time frame: less than two minutes
Laryngoscopy Time
Time frame: less than one minute
Overall First Attempt Success Rate
Time frame: average 1 minute
Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie
Time frame: average 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyprian Mendonca, Phd, MD FRCA principal investigator
University Hospitals Coventry & Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Bougie and Flexi-tip Bougie (P3 Medical Bristol,UK) in people with Intubation, Intratracheal, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Intubation Difficulty Scale Score (mIDS) (time frame: average 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.