NCT02277951

Brief Summary

The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model. The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Status
completed

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

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

October 16, 2014

Last Update Submit

October 27, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to successful intubation

    The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.

    Subjects complete study in 1 day

  • Success rate of ETI

    The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.

    Subjects complete study in 1 day

Study Arms (1)

Participants

The Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope

Device: The Bonfils Intubation FibrescopeDevice: The Video Rigid Flexing LaryngoscopeDevice: The C-MAC® S Video LaryngoscopeDevice: The Macintosh Laryngoscope

Interventions

Effectiveness and time to successful intubation will be measured.

Participants

Effectiveness and time to successful intubation will be measured.

Participants

Effectiveness and time to successful intubation will be measured.

Participants

Effectiveness and time to successful intubation will be measured.

Participants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Personnel of emergency medical services and hospital emergency units

You may qualify if:

  • experienced emergency personnel: nurses, paramedics

You may not qualify if:

  • no experience in out-of-hospital emergency medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 29, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-10