NCT02277015

Brief Summary

The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.

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
94

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
unknown

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
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4 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 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1 month

First QC Date

October 26, 2014

Last Update Submit

November 11, 2014

Conditions

Cardiac ArrestEndotracheal IntubationPediatric Manikin

Outcome Measures

Primary Outcomes (1)

  • Intubation Time

    time in seconds required for a successful intubation attempt with the five different ETI devices

    1 month

Secondary Outcomes (6)

  • Successful intubation

    1 month

  • POGO score

    1 month

  • VAS score

    1 month

  • Preferred ETI device

    1 month

  • First Pass Attempt

    1 month

  • +1 more secondary outcomes

Study Arms (2)

ETI without chest compressions

EXPERIMENTAL

Endotracheal intubation during pediatric resuscitation without chest compressions.

Device: Miller LaryngoscopeDevice: The Berci-Kaplan DCIDevice: The AirTraqDevice: GlideScope GVLDevice: The Pentax AWS

ETI with chest compressions

EXPERIMENTAL

Endotracheal intubation during pediatric resuscitation with chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control).

Device: Miller LaryngoscopeDevice: The Berci-Kaplan DCIDevice: The AirTraqDevice: GlideScope GVLDevice: The Pentax AWS

Interventions

Miller LaryngoscopeDEVICE

Direct Laryngoscopy

ETI with chest compressionsETI without chest compressions
The Berci-Kaplan DCIDEVICE

Videolaryngoscope-1

ETI with chest compressionsETI without chest compressions
The AirTraqDEVICE

Videolaryngoscope-2

ETI with chest compressionsETI without chest compressions
GlideScope GVLDEVICE

Videolaryngoscope-3

ETI with chest compressionsETI without chest compressions
The Pentax AWSDEVICE

Videolaryngoscope-4

ETI with chest compressionsETI 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 medicine personnel (physicians, nurses, paramedics)

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

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Szarpak

    National Institute of Cardiology, Warsaw, Poland

    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
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 26, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-10

Locations

PL(1)