NCT02694900

Brief Summary

The objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

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
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

February 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

29 days

First QC Date

February 16, 2016

Last Update Submit

March 12, 2016

Conditions

Chest Compression

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 (5)

  • Depth

    1 day

  • Pressure point

    1 day

  • Complete pressure release

    1 day

  • Rate of chest compressions

    1 day

  • Ease-of-use

    1 day

Study Arms (2)

Resuscitation on the flor

EXPERIMENTAL

2 min asynchronous cardiopulmonary resuscitation. The patient lies on the floor

Other: Manually chest compressionsDevice: CardiopumpDevice: LifeLine ARM

Resuscitation on the stretcher

EXPERIMENTAL

2 min asynchronous cardiopulmonary resuscitation. The patient lies on a stretcher

Other: Manually chest compressionsDevice: CardiopumpDevice: LifeLine ARM

Interventions

Manually chest compressionsOTHER

Chest compressions performed manually without any device

Resuscitation on the florResuscitation on the stretcher
CardiopumpDEVICE

Chest compressions performed with Cardiopump

Resuscitation on the florResuscitation on the stretcher
LifeLine ARMDEVICE

Chest compressions performed using mechanical chest compressions system LifeLine ARM

Resuscitation on the florResuscitation on the stretcher

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, nurses, physicians

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

Location

Related Publications (1)

  • 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

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
Principal Investigator

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 1, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

PL(1)