NCT02277418

Brief Summary

The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller laryngoscope during resuscitation with and without chest compressions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
3 days 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
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

October 27, 2014

Last Update Submit

November 13, 2014

Conditions

IntubationResuscitation

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.

    1 day

Secondary Outcomes (4)

  • Success of intubation

    1 day

  • POGO score

    1 day

  • VAS score

    1 day

  • Cormack-Lehan scale

    1 day

Study Arms (4)

Child ETI withoutchest compressions

EXPERIMENTAL

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Device: VAVLDevice: MIL

Child ETI with 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: VAVLDevice: MIL

Infant ETI with chest compressions

EXPERIMENTAL

endotracheal intubation (ETI) during infant mannikin resuscitation with uninterrupted chest compressions.

Device: VAVLDevice: MIL

Infant ETI without chest compressions

EXPERIMENTAL

Endotracheal intubation of infant mannikin during resuscitation without chest compressions.

Device: VAVLDevice: MIL

Interventions

VAVLDEVICE

Videolaryngoscope

Also known as: Venner a.p. advance video laryngoscope
Child ETI with chest compressionsChild ETI withoutchest compressionsInfant ETI with chest compressionsInfant ETI without chest compressions
MILDEVICE

Direct laryngoscopy

Also known as: Miller Laryngoscope
Child ETI with chest compressionsChild ETI withoutchest compressionsInfant ETI with chest compressionsInfant ETI 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, 03-122, Poland

Location

Study Officials

  • Lukasz Szarpak

    National Institute of Cardiology, Warsaw, Poland

    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

October 27, 2014

First Posted

October 29, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

PL(1)