ResuscitationProseCPRNCT05709665
Incidence of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany
An observational study of Resuscitation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in Germany. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resuscitation
- What is being tested?
- Time to Decision for eCPR
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2023to 31 Oct 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All cardiac arrest patients at a tertiary hospital
Who may be able to join
- All patients with a cardiac arrest
Who cannot join
- not complete fill out evaluation forms
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
Marc Kriege, MD, 00496131170, makiege@uni-mainz.de
Eva Wittenmeier, MD, 00496131170
About this study
Official title: Incidence and Special Informations From Patients of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany
Incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in Germany.
Read the detailed description
To evaluate background information for planning a eCPR Program at a tertiary hospital, the investigators planned a prospective study of every out- and in-hospital cardiac arrest.
- Conditions
- Resuscitation
- Being tested
- Time to Decision for eCPR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to Decision for eCPROther
Also called Pros eCPR
We evaluate during high quality CPR the time for decision for eCPR
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest | Patient characteristics; Rescue time intervals; Time to eCPR Decision during high quality CPR; Receives: Other: Time to Decision for eCPR | |
| In-hospital cardiac arrest | Patient characteristics; Emergency team time intervals; Time to eCPR Decision during high quality CPR; Receives: Other: Time to Decision for eCPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to eCPR Decision during high quality CPR
After established high quality CPR, we evaluate the time of decision for eCPR
Measured: < 10 Minutes
Secondary outcomes (2)
Patient characteristics
Age, BMI, comorbidity, contraindications for ECMO
Measured: < 10 Minutes
Rescue/Emergency team time intervals
Time to Achievement at the patient; Time for transport
Measured: < 60 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start11 Jan 2023
- Primary completion11 Jul 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709665
- Sponsor's protocol ID
- JohannesGUC
- Acronym
- ProseCPR
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Special Informations From Patients of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany
- ClinicalTrials.gov ID
- NCT05709665
- Acronym / sponsor ID
- ProseCPR / JohannesGUC
- Conditions
- Resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 11 Jul 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
Incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in Germany.
Detailed description
To evaluate background information for planning a eCPR Program at a tertiary hospital, the investigators planned a prospective study of every out- and in-hospital cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest | – | Other: Time to Decision for eCPRPatient characteristics; Rescue time intervals; Time to eCPR Decision during high quality CPR; |
| In-hospital cardiac arrest | – | Other: Time to Decision for eCPRPatient characteristics; Emergency team time intervals; Time to eCPR Decision during high quality CPR; |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All cardiac arrest patients at a tertiary hospital
Key inclusion criteria (1 listed)
- All patients with a cardiac arrest
Key exclusion criteria (1 listed)
- not complete fill out evaluation forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time to Decision for eCPRAlso: Pros eCPRWe evaluate during high quality CPR the time for decision for eCPR | Other | In-hospital cardiac arrest, Out-of-hospital cardiac arrest |
Primary outcome
Time to eCPR Decision during high quality CPR
Time frame: < 10 Minutes
After established high quality CPR, we evaluate the time of decision for eCPR
2 secondary outcomes
Patient characteristics
Time frame: < 10 Minutes
Rescue/Emergency team time intervals
Time frame: < 60 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Resuscitation
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
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)
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
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.
Marc Kriege, MD principal investigator
University Medical Center Mainz
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 Resuscitation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 inclusion and 1 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 3 Feb 2023. 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 Germany. 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 Marc Kriege, MD (00496131170, makriege@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to eCPR Decision during high quality CPR (time frame: < 10 Minutes). 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 3 Feb 2023.