- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05250453
Quality of the Cardio-pulmonary Resuscitation
Cardiopulmonary Resuscitation; Epidemiology, Quality, Survival and Injuries.
Patients having sudden cardiac arrest have very poor prognosis. It is devastating for patient and family. But also very expensive for nations economics when working-age people die or disable due to cardiac arrest. Recent studies have shown that high quality of cardiopulmonary resuscitation (CPR) and minimized delays increases the survival after cardiac arrest. In this objective prospective study we will use Zoll´s X Series defibrillator on every emergency medicine systems (EMS´s) unit in Pirkanmaa area, Finland, to collect information on CPR quality. Real CPR Help® will collect the information on depth, frequency and pauses during CPR. We will make an Utstein analysis on OHCA during one year period and compare the results on Utstein analysis made in the same area on 2013-2014. We will analyse the quality of CPR and compare it to the outcome from OHCA and neurological outcome 3 months after resuscitation. In addition we will analyse the CPR related injuries and compare these to the compression depth and number of persons performing CPR.
In one part of the study we will evaluate the incidence of OHCA in different risk areas of Pirkanmaa and analyse the influence of time delay and location to the outcome out of hospital and neurological outcome 3 months after resuscitation. We will also analyse if the time of post-resuscitation care before getting to the hospital or stenosis in carotid artery affects the outcome from OHCA and neurological outcome 3 months after resuscitation.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sanna Hoppu, PhD
- Phone Number: +3583311611
- Email: sanna.hoppu@pshp.fi
Study Contact Backup
- Name: Paula Mäki, MD
- Phone Number: +3583311611
- Email: paula.maki@pshp.fi
Study Locations
-
-
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Tampere, Finland, 33521
- Recruiting
- Tampere University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- cardiac arrest
- > 18 years of age
Exclusion Criteria:
- < 18 years of age
- prisoners
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cardiac arrest
All patients having sudden cardiac arrest out-of-hospital in Pirkanmaa, Finland
|
ResusInj
OHCA survivors having CPR related injuries or carotid stenosis analyzed by CT
|
ResusCPC
OHCA survivors neurological outcome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QualityCPR
Time Frame: 1 year
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The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
|
1 year
|
Neurological survival after CA
Time Frame: 3 months after OHCA
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Neurological survival after CA
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3 months after OHCA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPR related injuries
Time Frame: 1 year
|
Injuries detected in CT scanning or in autopsy
|
1 year
|
Stenosis of the carotid artery
Time Frame: 3 months after OHCA
|
Effect of the carotid artery stenosis to the neurological survival.
Survivals having CPC 1-2 prior to the cardiac arrest and are taken to the ICU are scanned with carotid CTA after informed consent.
The degree of stenosis will be compared to the CPC-level 3monts aften OHCA.
|
3 months after OHCA
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the dispatch calls concerning OHCA
Time Frame: 1 year
|
Analyze the key words and dispatch assisted CPR through the emergency call. All emergency call conserning OHCA patients will be listened. We will analyze the keywords which are used by layperson to describe patient having cardiac arrest. We will also analyze the amount of given dispatch assisted CPR and compare the amount to the primary rythm. |
1 year
|
the quality of the postresuscitation care
Time Frame: 3 months after OHCA
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The correlation of the duration and the quality of the postresuscitation care before getting in to the hospital and the outcome from OHCA
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3 months after OHCA
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Piritta Setälä, PhD, Tampere University Hospital
- Study Director: Sanna Hoppu, PhD, Tampere University Hospital
- Principal Investigator: Jyrki Ollikainen, MD, Tampere University Hospital
- Study Director: Kati Järvelä, PhD, Tampere University Hospital
- Principal Investigator: Valtteri Järvenpää, MB, Tampere University Hospital
- Study Director: Ville Jalkanen, PhD, Tampere University Hospital
- Study Director: Joonas Tirkkonen, PhD, Tampere University Hospital
- Study Director: Heini Huhtala, PhD, Tampere University
- Study Director: Mika Martiskainen, PhD, Finnish Institute for Health and Welfare
- Study Director: Riikka Nevalainen, MD, Tampere University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R18100
- R18163 (REGISTRY: ResusciCPC)
- R21124 (REGISTRY: ResusciCT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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