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Flexible Tip Bougie Catheter Intubation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03733158
Enrollment
32
Registered
2018-11-07
Start date
2019-03-01
Completion date
2019-05-30
Last updated
2019-06-19

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

Conditions

Cardiopulmonary Arrest, Emergency Medicine, Endotracheal Intubation

Keywords

endotracheal intubation, emergency medicine, cardiopulmonary resuscitation, physician

Brief 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 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.

Interventions

DEVICEthe standard Bougie stylet for difficult intubation

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

DEVICEThe new Flexible Tip Bougie catheter

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Sponsors

Lazarski University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

Inclusion criteria

* physicians * give voluntary consent to participate in the study * none experience in videolaryngoscopy * less than 1 year experience in medicine

Exclusion criteria

* not meet the above criteria * wrist or low back diseases

Design outcomes

Primary

MeasureTime frameDescription
time to intubation1 daytime from pick up device to the final placement tube in trachea

Secondary

MeasureTime frameDescription
success of intubation1 dayA failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform
Number of optimalization maneuvers1 daythe number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
Ease of use1 dayself-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
Dental compression1 dayAn 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).

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026