Flexible Tip Bougie Catheter Intubation

NCT ID: NCT03733158

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-05-30

Brief Summary

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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

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Conditions

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Emergency Medicine Endotracheal Intubation Cardiopulmonary Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Normal airway

intubation in normal aurway condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Tongue edema

intubation in Tongue edema condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Pharyngeal obstruction

intubation in Tongue edema condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Manual cervical inline stabilization

intubation in Manual cervical inline stabilization condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Cervical collar stabilization

intubation in Cervical collar stabilization condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Cervical collar stabilization and pharyngeal obstruction

intubation in Cervical collar stabilization and pharyngeal obstruction condition

Group Type EXPERIMENTAL

the standard Bougie stylet for difficult intubation

Intervention Type DEVICE

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

The new Flexible Tip Bougie catheter

Intervention Type DEVICE

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Interventions

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the standard Bougie stylet for difficult intubation

intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter

Intervention Type DEVICE

The new Flexible Tip Bougie catheter

intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lazarski University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukasz Szarpak, Phd

Role: PRINCIPAL_INVESTIGATOR

Lazarski University

Locations

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Lazarski University

Warsaw, Masovia, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 32312225 (View on PubMed)

Other Identifiers

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INT_2018_UL

Identifier Type: -

Identifier Source: org_study_id

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