BradycardiaNCT02711748
Can Medical Personnel Properly Proceed in the Case of a Patient With Bradycardia?
A study testing electrostimulation and cardiopulmonary resuscitation in people with Bradycardia, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aims to assess the regularity of the proceedings in the case of a patient with bradycardia ECG. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bradycardia
- What is being tested?
- electrostimulation and cardiopulmonary resuscitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Mar 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- paramedics, nurses, physicians
Who cannot join
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
Lukasz Szarpak, PhD, +48500186225, lukasz.szarpak@gmail.com
About this study
The study aims to assess the regularity of the proceedings in the case of a patient with bradycardia ECG.
- Conditions
- Bradycardia
- Being tested
- electrostimulation, cardiopulmonary resuscitation
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrostimulationDevice
Electrostimulation using manual defibrillator
cardiopulmonary resuscitationDevice
CPR according to guidelines of European Resuscitation Council. Cardiopulmonary resuscitation using manual defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Bradycardia | Experimental | Treatment In case of bradycardia. The patient unconscious, breathing preserved in ECG - bradycardia 40 / min with pulse. Receives: Device: electrostimulation |
| PEA | Experimental | In case of bradycardia. The patient unconscious, not breathing, the ECG - bradycardia 30 / min - no pulse. Pulseless electrical activity Receives: Device: cardiopulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to assess effectiveness of the rhythm recognition and participants' knowledge on life-threatening rhythms
The effectiveness of the rhythm recognition. participants knowledge on life-threatening rhythms
Measured: intraoperative
Secondary outcomes (1)
Time to take proper action
time from rhythm interpretation to proper conduct
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711748
- Sponsor's protocol ID
- 02.012.1MR
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Medical Personnel Properly Proceed in the Case of a Patient With Bradycardia?
- ClinicalTrials.gov ID
- NCT02711748
- Acronym / sponsor ID
- 02.012.1MR
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
The study aims to assess the regularity of the proceedings in the case of a patient with bradycardia ECG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bradycardia | Experimental | Device: electrostimulationTreatment In case of bradycardia. The patient unconscious, breathing preserved in ECG - bradycardia 40 / min with pulse. |
| PEA | Experimental | Device: cardiopulmonary resuscitationIn case of bradycardia. The patient unconscious, not breathing, the ECG - bradycardia 30 / min - no pulse. Pulseless electrical activity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- paramedics, nurses, physicians
Key exclusion criteria (3 listed)
- not meet the above criteria
- wrist or low back diseases
- pregnancy
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 |
|---|---|---|
| electrostimulationElectrostimulation using manual defibrillator | Device | Bradycardia |
| cardiopulmonary resuscitationCPR according to guidelines of European Resuscitation Council. Cardiopulmonary resuscitation using manual defibrillator | Device | PEA |
Primary outcome
Questionnaire to assess effectiveness of the rhythm recognition and participants' knowledge on life-threatening rhythms
Time frame: intraoperative
The effectiveness of the rhythm recognition. participants knowledge on life-threatening rhythms
1 secondary outcome
Time to take proper action
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrostimulation and cardiopulmonary resuscitation in people with Bradycardia, run by Medical University of Warsaw at 1 site in Poland.
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 3 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 17 Mar 2016. 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 Poland. 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 Lukasz Szarpak, PhD (+48500186225, lukasz.szarpak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire to assess effectiveness of the rhythm recognition and participants' knowledge on life-threatening rhythms (time frame: intraoperative). 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 17 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.