NCT02286323

Brief Summary

We hypothesized that the BONFILS is beneficial for intubation of manikins while performing CPR. In the current study we compared the performance of the BONFILS and the Macintosh laryngoscopes with respect to their effectiveness and time to successful ETI during chest compression (CC) using an adult manikin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

November 5, 2014

Last Update Submit

November 7, 2014

Conditions

Cardiac Arrest

Keywords

Intubation, Endotracheal

Outcome Measures

Primary Outcomes (1)

  • Time to intubation

    time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.

    intraoperative

Secondary Outcomes (2)

  • Success of intubation

    intraoperative

  • POGO score

    1 day

Study Arms (2)

Endotracheal intubation without chest compressions

EXPERIMENTAL

Endotracheal intubation of mannikin during resuscitation without chest compressions.

Device: BonfilsDevice: Macintosh

Endotracheal intubation with uninterrupted chest compressions

EXPERIMENTAL

Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

Device: BonfilsDevice: Macintosh

Interventions

BonfilsDEVICE

Bonfils Intubation Fiberoscope

Endotracheal intubation with uninterrupted chest compressionsEndotracheal intubation without chest compressions
MacintoshDEVICE

Direct laryngoscopy using Macintosh Laryngoscope

Endotracheal intubation with uninterrupted chest compressionsEndotracheal intubation without chest compressions

Eligibility Criteria

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

You may qualify if:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel (paramedics, nurses, physicians)

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)

International Institute of Rescue Research and Education

Warsaw, Masovia, 04-628, Poland

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andrzej Kurowski

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

PL(1)