Cardiogenic ShockNCT05331001
Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation
An observational study of Cardiogenic Shock and Myocardial Infarction, run by Charite University, Berlin, Germany.
Trial summary
Cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Myocardial Infarction, Cardiac Arrest
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 30 Mar 2023
- How long will I take part?
- 7 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Permament adult staff which is employed in a cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO). Medical doctors and nurses are included.
Who may be able to join
- Adult medical doctors or nurses
- Permament staff in the cardiac arrest center
- Cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO)
Who cannot join
- No permanent employment in a cardiac arrest center
- Non-adult staff
- Not a medical doctor or nurse
- Cardiac arrest center that does not provide therapy with ECMO
Trial locations and contacts
No sites are listed yet.
About this study
Cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. Diagnostic and therapeutic measures, such as the use of devices for extracorporeal life support, require highly specialized training and skills. Apart from extensive medical expertise, physicians and nurses may be exposed to exceptional levels of occupational stressors. Therefore, excellent medical, psychological and inter-personal training of the medical staff is essential to improve patient outcomes. Assessment of quality of care is important to provide continuous improvement in patient care and team performance. To the best of our knowledge, there is no study which examined the quality of care in cardiac arrest centers across key dimensions of quality of care. Therefore, we aim to assess a bundle of key dimensions, that is psychological strain (P), resource utilization (R), interaction (I) between doctoral and nursing staff, costs of care (C) and education (E) programs for staff (PRICE scheme). A cross-sectional study will be conducted with doctors and nurses, using a digital quesitonnaire that will cover the five dimensions of the PRICE scheme.
- Conditions
- Cardiogenic Shock, Myocardial Infarction, Cardiac Arrest, Extracorporeal Circulation; Complications
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction, Heart Arrest
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 |
|---|---|---|
| Medical doctors | Medical doctors who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation. | |
| Nurses | Nurses who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological strain (P)
The psychologial strain of permanent staff in the cardiac arrest center will be assessed based on a standardized questionnaire.
Measured: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Secondary outcomes (4)
Ressource utilization (R)
The availability of material and non-material ressources and the extent of ressource utilization in the cardiac arrest center will be assessed based on a standardized questionnaire.
Measured: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Interaction (I)
The quality of inter-professional interactions between medical doctors and nurses in the cardiac arrest center will be assessed based on a standardized questionnaire.
Measured: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Costs (C) of care
The costs of care in the cardiac arrest center will be assessed based on a standardized questionnaire.
Measured: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Education (E) programs
The availability and quality of education programs in the cardiac arrest center will be assessed based on a standardized questionnaire.
Measured: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tharusan Thevathasan, Charite University, Berlin, Germany
- Investigators
- Carsten Skurk, MD, Study director, Charite UniversityTharusan Thevathasan, MD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331001
- Sponsor's protocol ID
- ECMO Quality of Care
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT05331001
- Acronym / sponsor ID
- ECMO Quality of Care
- Conditions
- Cardiogenic Shock, Myocardial Infarction, Cardiac Arrest, Extracorporeal Circulation; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 15 Apr 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.
Cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. Diagnostic and therapeutic measures, such as the use of devices for extracorporeal life support, require highly specialized training and skills. Apart from extensive medical expertise, physicians and nurses may be exposed to exceptional levels of occupational stressors. Therefore, excellent medical, psychological and inter-personal training of the medical staff is essential to improve patient outcomes. Assessment of quality of care is important to provide continuous improvement in patient care and team performance. To the best of our knowledge, there is no study which examined the quality of care in cardiac arrest centers across key dimensions of quality of care. Therefore, we aim to assess a bundle of key dimensions, that is psychological strain (P), resource utilization (R), interaction (I) between doctoral and nursing staff, costs of care (C) and education (E) programs for staff (PRICE scheme). A cross-sectional study will be conducted with doctors and nurses, using a digital quesitonnaire that will cover the five dimensions of the PRICE scheme.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical doctors | – | –Medical doctors who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation. |
| Nurses | – | –Nurses who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Permament adult staff which is employed in a cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO). Medical doctors and nurses are included.
Key inclusion criteria (3 listed)
- Adult medical doctors or nurses
- Permament staff in the cardiac arrest center
- Cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO)
Key exclusion criteria (4 listed)
- No permanent employment in a cardiac arrest center
- Non-adult staff
- Not a medical doctor or nurse
- Cardiac arrest center that does not provide therapy with ECMO
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
Psychological strain (P)
Time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
The psychologial strain of permanent staff in the cardiac arrest center will be assessed based on a standardized questionnaire.
4 secondary outcomes
Ressource utilization (R)
Time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Interaction (I)
Time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Costs (C) of care
Time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Education (E) programs
Time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Carsten Skurk, MD study director
Charite University
Tharusan Thevathasan, MD principal investigator
Charite University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Myocardial Infarction, run by Charite University, Berlin, 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 3 inclusion and 4 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Tharusan Thevathasan, MD (+4915774407864, tharusan.thevathasan@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological strain (P) (time frame: During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.). 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 18 Apr 2022.