- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02703103
Chest Compression During Resuscitation
April 5, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw
Use of a New Mechanical Chest Compression Machine LifeLine ARM for Cardiopulmonary Resuscitation by Paramedics: a Randomized, Crossover, Manikin Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Warszawa, Poland, 00-832
- Recruiting
- Łukasz Szarpak
-
Contact:
- Łukasz Szarpak
- Phone Number: 500186225
- Email: lukasz.szarpak@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 10 clinical resuscitations
- paramedics
Exclusion Criteria:
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Standard cardiopulmonary resuscitation
standard CPR (30:2) according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.
|
2 min of Chest compressions without mechanical chest compression system
2 min of Chest compressions with mechanical chest compression system LifeLine ARM
|
EXPERIMENTAL: asynchronous cardiopulmonary resuscitation
asynchronuos CPR according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation.
|
2 min of Chest compressions without mechanical chest compression system
2 min of Chest compressions with mechanical chest compression system LifeLine ARM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chest compressions effectiveness
Time Frame: 1 day
|
the percentage of correct chest compressions relative to the total number of chest compressions
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete pressure release
Time Frame: 1 day
|
Complete pressure release measure by manikin software
|
1 day
|
Depth
Time Frame: 1 day
|
correct depth according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
|
1 day
|
Pressure point
Time Frame: 1 day
|
correct pressure point according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
|
1 day
|
Rate of chest compressions
Time Frame: 1 day
|
correct chest compressions rate according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
|
1 day
|
hands-off time
Time Frame: 1 day
|
defined as the sum of all periods during which no hand was placed on the chest minus time used for ventilation.
|
1 day
|
tidal volume
Time Frame: 1 day
|
volume of air delivered in a single rescue breath in milliliters
|
1 day
|
ventilation rate
Time Frame: 1 day
|
respiratory rate per minute
|
1 day
|
minute-volume
Time Frame: 1 day
|
minute volume ventilation
|
1 day
|
number of gastric inflations
Time Frame: 1 day
|
number of gastric inflations
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (ANTICIPATED)
April 1, 2016
Study Completion (ANTICIPATED)
April 1, 2016
Study Registration Dates
First Submitted
February 16, 2016
First Submitted That Met QC Criteria
March 3, 2016
First Posted (ESTIMATE)
March 9, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 02.008.1MR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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