Emergency MedicineNCT03733158
Flexible Tip Bougie Catheter Intubation
A study testing the standard Bougie stylet for difficult intubation and The new Flexible Tip Bougie catheter in people with Emergency Medicine and Endotracheal Intubation, run by Lazarski University at 1 site in Poland.
Trial summary
We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Medicine, Endotracheal Intubation, Cardiopulmonary Arrest
- What is being tested?
- the standard Bougie stylet for difficult intubation and The new Flexible Tip Bougie catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2019to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physicians
- give voluntary consent to participate in the study
- none experience in videolaryngoscopy
- less than 1 year experience in medicine
Who cannot join
- not meet the above criteria
- wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial
We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.
- Being tested
- the standard Bougie stylet for difficult intubation, The new Flexible Tip Bougie catheter
- Keywords
- endotracheal intubation, emergency medicine, cardiopulmonary resuscitation, physician
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the standard Bougie stylet for difficult intubationDevice
intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter
The new Flexible Tip Bougie catheterDevice
intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
| Study group | Role | What they receive |
|---|---|---|
| Normal airway | Experimental | intubation in normal aurway condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
| Tongue edema | Experimental | intubation in Tongue edema condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
| Pharyngeal obstruction | Experimental | intubation in Tongue edema condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
| Manual cervical inline stabilization | Experimental | intubation in Manual cervical inline stabilization condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
| Cervical collar stabilization | Experimental | intubation in Cervical collar stabilization condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
| Cervical collar stabilization and pharyngeal obstruction | Experimental | intubation in Cervical collar stabilization and pharyngeal obstruction condition Receives: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
time from pick up device to the final placement tube in trachea
Measured: 1 day
Secondary outcomes (4)
success of intubation
A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform
Measured: 1 day
Number of optimalization maneuvers
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
Measured: 1 day
Ease of use
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
Measured: 1 day
Dental compression
An independent observer scored the severity of dental compressions, which was calculated based on the number of audible teeth clicks (0; 1; ≥2) with the Laerdal airway trainer, and based on a grading of pressure of the teeth (none = 0; mild = 1; moderate/serve ≥2) on the Simman®3G simulator. At the end of each scenario, each participant scored the ease of use of each intubation method on a visual analogue scale (VAS; from 0=Extremely Easy to 100=Extremely Difficult).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Mar 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency MedicineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukasz Szarpak, Phd, Principal investigator, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733158
- Sponsor's protocol ID
- INT_2018_UL
- Status last verified
- Jun 2019
- First submitted
- 5 Nov 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available from the main investigator
Publications
Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.
PubMed 32312225
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03733158
- Acronym / sponsor ID
- INT_2018_UL
- Keywords
- endotracheal intubation, emergency medicine, cardiopulmonary resuscitation, physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Normal airway | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in normal aurway condition |
| Tongue edema | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in Tongue edema condition |
| Pharyngeal obstruction | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in Tongue edema condition |
| Manual cervical inline stabilization | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in Manual cervical inline stabilization condition |
| Cervical collar stabilization | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in Cervical collar stabilization condition |
| Cervical collar stabilization and pharyngeal obstruction | Experimental | Device: the standard Bougie stylet for difficult intubation, Device: The new Flexible Tip Bougie catheterintubation in Cervical collar stabilization and pharyngeal obstruction condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- physicians
- give voluntary consent to participate in the study
- none experience in videolaryngoscopy
- less than 1 year experience in medicine
Key exclusion criteria (2 listed)
- not meet the above criteria
- wrist or low back diseases
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 |
|---|---|---|
| the standard Bougie stylet for difficult intubationintubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter | Device | Cervical collar stabilization, Cervical collar stabilization and pharyngeal obstruction, Manual cervical inline stabilization, Normal airway, Pharyngeal obstruction, Tongue edema |
| The new Flexible Tip Bougie catheterintubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter | Device | Cervical collar stabilization, Cervical collar stabilization and pharyngeal obstruction, Manual cervical inline stabilization, Normal airway, Pharyngeal obstruction, Tongue edema |
Primary outcome
time to intubation
Time frame: 1 day
time from pick up device to the final placement tube in trachea
4 secondary outcomes
success of intubation
Time frame: 1 day
Number of optimalization maneuvers
Time frame: 1 day
Ease of use
Time frame: 1 day
Dental compression
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 32312225Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.
- Individual participant dataSharing planned: Undecided. data will be available from the main investigator
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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.
Lukasz Szarpak, Phd principal investigator
Lazarski University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the standard Bougie stylet for difficult intubation and The new Flexible Tip Bougie catheter in people with Emergency Medicine and Endotracheal Intubation, run by Lazarski University at 1 site in Poland.
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 4 inclusion and 2 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 19 Jun 2019. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to intubation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733158, which also lists 1 linked publication.
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 19 Jun 2019.