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Flexible Tip Bougie Catheter Intubation

Primary Purpose

Emergency Medicine, Endotracheal Intubation, Cardiopulmonary Arrest

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
the standard Bougie stylet for difficult intubation
The new Flexible Tip Bougie catheter
Sponsored by
Lazarski University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergency Medicine focused on measuring endotracheal intubation, emergency medicine, cardiopulmonary resuscitation, physician

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lazarski University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal airway

Tongue edema

Pharyngeal obstruction

Manual cervical inline stabilization

Cervical collar stabilization

Cervical collar stabilization and pharyngeal obstruction

Arm Description

intubation in normal aurway condition

intubation in Tongue edema condition

intubation in Tongue edema condition

intubation in Manual cervical inline stabilization condition

intubation in Cervical collar stabilization condition

intubation in Cervical collar stabilization and pharyngeal obstruction condition

Outcomes

Primary Outcome Measures

time to intubation
time from pick up device to the final placement tube in trachea

Secondary Outcome Measures

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
Number of optimalization maneuvers
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
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
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).

Full Information

First Posted
November 5, 2018
Last Updated
June 17, 2019
Sponsor
Lazarski University
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1. Study Identification

Unique Protocol Identification Number
NCT03733158
Brief Title
Flexible Tip Bougie Catheter Intubation
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lazarski University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Medicine, Endotracheal Intubation, Cardiopulmonary Arrest
Keywords
endotracheal intubation, emergency medicine, cardiopulmonary resuscitation, physician

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal airway
Arm Type
Experimental
Arm Description
intubation in normal aurway condition
Arm Title
Tongue edema
Arm Type
Experimental
Arm Description
intubation in Tongue edema condition
Arm Title
Pharyngeal obstruction
Arm Type
Experimental
Arm Description
intubation in Tongue edema condition
Arm Title
Manual cervical inline stabilization
Arm Type
Experimental
Arm Description
intubation in Manual cervical inline stabilization condition
Arm Title
Cervical collar stabilization
Arm Type
Experimental
Arm Description
intubation in Cervical collar stabilization condition
Arm Title
Cervical collar stabilization and pharyngeal obstruction
Arm Type
Experimental
Arm Description
intubation in Cervical collar stabilization and pharyngeal obstruction condition
Intervention Type
Device
Intervention Name(s)
the standard Bougie stylet for difficult intubation
Intervention Description
intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter
Intervention Type
Device
Intervention Name(s)
The new Flexible Tip Bougie catheter
Intervention Description
intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
Primary Outcome Measure Information:
Title
time to intubation
Description
time from pick up device to the final placement tube in trachea
Time Frame
1 day
Secondary Outcome Measure Information:
Title
success of intubation
Description
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
Time Frame
1 day
Title
Number of optimalization maneuvers
Description
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
Time Frame
1 day
Title
Ease of use
Description
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
Time Frame
1 day
Title
Dental compression
Description
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).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak, Phd
Organizational Affiliation
Lazarski University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lazarski University
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
02-662
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
data will be available from the main investigator
Citations:
PubMed Identifier
32312225
Citation
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.
Results Reference
derived

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Flexible Tip Bougie Catheter Intubation

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