Endotracheal Intubation Clinical Trial
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
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 |
Verified date | June 2019 |
Source | Lazarski University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Lazarski University | Warsaw | Masovia |
Lead Sponsor | Collaborator |
---|---|
Lazarski University |
Poland,
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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