NCT02703103

Brief Summary

The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

February 16, 2016

Last Update Submit

April 5, 2016

Conditions

Keywords

cardiopulmonary resuscitationchest compressionadultsimulation

Outcome Measures

Primary Outcomes (1)

  • chest compressions effectiveness

    the percentage of correct chest compressions relative to the total number of chest compressions

    1 day

Secondary Outcomes (9)

  • Depth

    1 day

  • Pressure point

    1 day

  • Complete pressure release

    1 day

  • Rate of chest compressions

    1 day

  • hands-off time

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Standard cardiopulmonary resuscitation

EXPERIMENTAL

standard CPR (30:2) according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.

Other: Manual chest compressionsDevice: ARM chest compressions

asynchronous cardiopulmonary resuscitation

EXPERIMENTAL

asynchronuos CPR according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.

Other: Manual chest compressionsDevice: ARM chest compressions

Interventions

2 min of Chest compressions without mechanical chest compression system

Standard cardiopulmonary resuscitationasynchronous cardiopulmonary resuscitation

2 min of Chest compressions with mechanical chest compression system LifeLine ARM

Standard cardiopulmonary resuscitationasynchronous cardiopulmonary resuscitation

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
  • maximum 1 year of work experience in medicine
  • minimum 10 clinical resuscitations
  • paramedics

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Łukasz Szarpak

Warsaw, 00-832, Poland

RECRUITING

Related Publications (2)

  • Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.

    PMID: 26612703BACKGROUND
  • Kurowski A, Czyzewski L, Bogdanski L, Zasko P, Karczewska K, Szarpak L. Quality of chest compression with CardioPump CPR compared to single rescuer standard BLS. Am J Emerg Med. 2015 Jan;33(1):114-5. doi: 10.1016/j.ajem.2014.10.027. Epub 2014 Oct 20. No abstract available.

    PMID: 25455057BACKGROUND

Central Study Contacts

Lukasz Szarpak, PhD

CONTACT

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
Łukasz Szarpak

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations