Flexible Tip Bougie Catheter Intubation

Not Applicable

Completed

• Conditions: Emergency Medicine; Endotracheal Intubation; Cardiopulmonary Arrest
• Interventions: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter

• Registration Number: NCT03733158
• Lead Sponsor: Lazarski University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-07
• Study Start: 2019-03-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pharyngeal obstruction	the standard Bougie stylet for difficult intubation	intubation in Tongue edema condition
Normal airway	the standard Bougie stylet for difficult intubation	intubation in normal aurway condition
Tongue edema	the standard Bougie stylet for difficult intubation	intubation in Tongue edema condition
Normal airway	The new Flexible Tip Bougie catheter	intubation in normal aurway condition
Cervical collar stabilization	The new Flexible Tip Bougie catheter	intubation in Cervical collar stabilization condition
Pharyngeal obstruction	The new Flexible Tip Bougie catheter	intubation in Tongue edema condition
Manual cervical inline stabilization	The new Flexible Tip Bougie catheter	intubation in Manual cervical inline stabilization condition
Cervical collar stabilization	the standard Bougie stylet for difficult intubation	intubation in Cervical collar stabilization condition
Tongue edema	The new Flexible Tip Bougie catheter	intubation in Tongue edema condition
Cervical collar stabilization and pharyngeal obstruction	the standard Bougie stylet for difficult intubation	intubation in Cervical collar stabilization and pharyngeal obstruction condition
Manual cervical inline stabilization	the standard Bougie stylet for difficult intubation	intubation in Manual cervical inline stabilization condition
Cervical collar stabilization and pharyngeal obstruction	The new Flexible Tip Bougie catheter	intubation in Cervical collar stabilization and pharyngeal obstruction condition

Primary Outcome Measures

Name	Time	Method
time to intubation	1 day	time from pick up device to the final placement tube in trachea

Secondary Outcome Measures

Name	Time	Method
Ease of use	1 day	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
Number of optimalization maneuvers	1 day	the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
success of intubation	1 day	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
Dental compression	1 day	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).

Trial Locations

Locations (1)

Lazarski University; 🇵🇱 Warsaw, Masovia, Poland