Flexible Tip Bougie Catheter Intubation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733158
• Other study ID #: INT_2018_UL
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Emergencies
• Emergency Medicine
• Endotracheal Intubation
• Heart Arrest

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