Cardiopulmonary ResuscitationNCT05250453
Quality of the Cardio-pulmonary Resuscitation
An observational study of Cardiopulmonary Resuscitation, run by Tampere University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiopulmonary Resuscitation
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2022to 1 Jul 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cardiac arrest patients in Etelä-Pohjanmaa and Pirkanmaa, Finland
Who may be able to join
- cardiac arrest
- > 18 years of age
Who cannot join
- < 18 years of age
- prisoners
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University hospital
Tampere, 33521
Sanna Hoppu, MD, PhD, 3583311611, sanna.hoppu@pshp.fi
About this study
Official title: 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.
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- CPR, injuries, OHCA
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
QualityCPR
The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
Measured: 1 year
Neurological survival after CA
Neurological survival after CA
Measured: 3 months after OHCA
Secondary outcomes (4)
CPR related injuries
Injuries detected in CT scanning or in autopsy
Measured: 1 year
Stenosis of the carotid artery
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.
Measured: 3 months after OHCA
the dispatch calls concerning OHCA
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.
Measured: 1 year
the quality of the postresuscitation care
The correlation of the duration and the quality of the postresuscitation care before getting in to the hospital and the outcome from OHCA
Measured: 3 months after OHCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Istitute For Health and Welfare, Finland
- Responsible party
- Sponsor
- Investigators
- Piritta Setälä, PhD, Study director, Tampere University HospitalSanna Hoppu, PhD, Study director, Tampere University HospitalJyrki Ollikainen, MD, Principal investigator, Tampere University HospitalKati Järvelä, PhD, Study director, Tampere University HospitalValtteri Järvenpää, MB, Principal investigator, Tampere University HospitalVille Jalkanen, PhD, Study director, Tampere University HospitalJoonas Tirkkonen, PhD, Study director, Tampere University HospitalHeini Huhtala, PhD, Study director, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250453
- Sponsor's protocol ID
- R18100
- Other IDs
- R18163, R21124
- Status last verified
- Feb 2022
- First submitted
- 3 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Resuscitation; Epidemiology, Quality, Survival and Injuries.
- ClinicalTrials.gov ID
- NCT05250453
- Acronym / sponsor ID
- R18100
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- CPR, injuries, OHCA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- National Istitute For Health and Welfare, Finland
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cardiac arrest patients in Etelä-Pohjanmaa and Pirkanmaa, Finland
Key inclusion criteria (2 listed)
- cardiac arrest
- > 18 years of age
Key exclusion criteria (2 listed)
- < 18 years of age
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QualityCPR
Time frame: 1 year
The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
Neurological survival after CA
Time frame: 3 months after OHCA
Neurological survival after CA
4 secondary outcomes
CPR related injuries
Time frame: 1 year
Stenosis of the carotid artery
Time frame: 3 months after OHCA
the dispatch calls concerning OHCA
Time frame: 1 year
the quality of the postresuscitation care
Time frame: 3 months after OHCA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Resuscitation
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piritta Setälä, PhD study director
Tampere University Hospital
Sanna Hoppu, PhD study director
Tampere University Hospital
Jyrki Ollikainen, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Resuscitation, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanna Hoppu, PhD (+3583311611, sanna.hoppu@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QualityCPR (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.