NCT03733158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

November 5, 2018

Last Update Submit

June 17, 2019

Conditions

Emergency MedicineEndotracheal IntubationCardiopulmonary Arrest

Keywords

endotracheal intubationemergency medicinecardiopulmonary resuscitationphysician

Outcome Measures

Primary Outcomes (1)

  • time to intubation

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

    1 day

Secondary Outcomes (4)

  • success of intubation

    1 day

  • Number of optimalization maneuvers

    1 day

  • Ease of use

    1 day

  • Dental compression

    1 day

Study Arms (6)

Normal airway

EXPERIMENTAL

intubation in normal aurway condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Tongue edema

EXPERIMENTAL

intubation in Tongue edema condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Pharyngeal obstruction

EXPERIMENTAL

intubation in Tongue edema condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Manual cervical inline stabilization

EXPERIMENTAL

intubation in Manual cervical inline stabilization condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Cervical collar stabilization

EXPERIMENTAL

intubation in Cervical collar stabilization condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Cervical collar stabilization and pharyngeal obstruction

EXPERIMENTAL

intubation in Cervical collar stabilization and pharyngeal obstruction condition

Device: the standard Bougie stylet for difficult intubationDevice: The new Flexible Tip Bougie catheter

Interventions

the standard Bougie stylet for difficult intubationDEVICE

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

Cervical collar stabilizationCervical collar stabilization and pharyngeal obstructionManual cervical inline stabilizationNormal airwayPharyngeal obstructionTongue edema
The new Flexible Tip Bougie catheterDEVICE

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

Cervical collar stabilizationCervical collar stabilization and pharyngeal obstructionManual cervical inline stabilizationNormal airwayPharyngeal obstructionTongue edema

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physicians
  • give voluntary consent to participate in the study
  • none experience in videolaryngoscopy
  • less than 1 year experience in medicine

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lazarski University

Warsaw, Masovia, 02-662, Poland

Location

Related Publications (1)

  • 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.

    PMID: 32312225DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Szarpak, Phd

    Lazarski University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

March 1, 2019

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

PL(1)