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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03733158
Other study ID # INT_2018_UL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date May 30, 2019

Study information

Verified date June 2019
Source Lazarski University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 30, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
the standard Bougie stylet for difficult intubation
intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter
The new Flexible Tip Bougie catheter
intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Locations

Country Name City State
Poland Lazarski University Warsaw Masovia

Sponsors (1)

Lead Sponsor Collaborator
Lazarski University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to intubation time from pick up device to the final placement tube in trachea 1 day
Secondary 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 1 day
Secondary Number of optimalization maneuvers the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation. 1 day
Secondary 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 1 day
Secondary 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). 1 day
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