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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Emergency Medicine; Cardiopulmonary Arrest
• Intervention / Treatment: Device: the standard Bougie stylet for difficult intubation; Device: The new Flexible Tip Bougie catheter

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Masovia
    • Warsaw, Masovia, Poland, 02-662
      • Lazarski University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal airway; intubation in normal aurway condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
EXPERIMENTAL: Tongue edema; intubation in Tongue edema condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
EXPERIMENTAL: Pharyngeal obstruction; intubation in Tongue edema condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
EXPERIMENTAL: Manual cervical inline stabilization; intubation in Manual cervical inline stabilization condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
EXPERIMENTAL: Cervical collar stabilization; intubation in Cervical collar stabilization condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
EXPERIMENTAL: Cervical collar stabilization and pharyngeal obstruction; intubation in Cervical collar stabilization and pharyngeal obstruction condition	Device: the standard Bougie stylet for difficult intubation; intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter; Device: The new Flexible Tip Bougie catheter; intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to intubation	time from pick up device to the final placement tube in trachea	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of optimalization maneuvers	the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.	1 day
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
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

Collaborators and Investigators

• Sponsor: Lazarski University

Publications and helpful links

General Publications

• Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. 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. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): May 30, 2019
• Study Completion (ACTUAL): May 30, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (ACTUAL): November 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: endotracheal intubation; cardiopulmonary resuscitation; physician; emergency medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest
• Other Study ID Numbers: INT_2018_UL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data will be available from the main investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No