Cardiac ArrestNCT00641069
Automated Chest Compression in Cardiac Arrest
An observational study of Cardiac Arrest, run by Beaujon Hospital at 1 site in France.
Trial summary
To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Automated load-distributing band device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Jan 2009
- 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: Patients aged > 18 with out-of-hospital cardiac arrest
Who may be able to join
- Age ≥ 18
- Refractory cardiac arrest
Who cannot join
- Defective invasive arterial blood pressure monitoring
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
Clichy, 92110
About this study
Official title: Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation
To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.
Read the detailed description
The protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (AutoPulse™ 100, Zoll®) with those of manual cardiopulmonary resuscitation in refractory out-of-hospital cardiac arrest. Each patient will receive first manual compressions and then automated resuscitation.
Patients presenting with cardiac arrest are treated following standard advanced life support guidelines. They are intubated and ventilated, received epinephrine and defibrillation if appropriate. Manuel chest compressions are continued. An arterial catheter is placed to monitor hemodynamics continuously as we usually do in this case. Patients are included at this stage. Three blood pressure values (every 1 minutes) are recorded. Then, the automated band device is started up without any pause, following our procedure for refractory cardiac arrest. Three blood pressure values are recorded again, during automated cardiopulmonary resuscitation.
- Conditions
- Cardiac Arrest
- Being tested
- Automated load-distributing band device
- Keywords
- Cardiac arrest, Cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated load-distributing band deviceDevice
Also called AutoPulse™ 100, Zoll®
Blood pressure recording before and after starting up the automated band device
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Measured: Instantaneously
Secondary outcomes (2)
Systolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Measured: Instantaneously
Mean blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Measured: Instantaneously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Francois-Xavier Duchateau, MD, Principal investigator, Departement of Anesthesiology, Intensive Care and EMS, Beaujon University HospitalJean Mantz, MDPhD, Study chair, Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641069
- Sponsor's protocol ID
- BAND V6
- Status last verified
- Jul 2009
- First submitted
- 18 Mar 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation
- ClinicalTrials.gov ID
- NCT00641069
- Acronym / sponsor ID
- BAND V6
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Cardiopulmonary resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Mar 2008 (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.
To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.
Detailed description
The protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (AutoPulse™ 100, Zoll®) with those of manual cardiopulmonary resuscitation in refractory out-of-hospital cardiac arrest. Each patient will receive first manual compressions and then automated resuscitation.
Patients presenting with cardiac arrest are treated following standard advanced life support guidelines. They are intubated and ventilated, received epinephrine and defibrillation if appropriate. Manuel chest compressions are continued. An arterial catheter is placed to monitor hemodynamics continuously as we usually do in this case. Patients are included at this stage. Three blood pressure values (every 1 minutes) are recorded. Then, the automated band device is started up without any pause, following our procedure for refractory cardiac arrest. Three blood pressure values are recorded again, during automated cardiopulmonary resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 18 with out-of-hospital cardiac arrest
Key inclusion criteria (2 listed)
- Age ≥ 18
- Refractory cardiac arrest
Key exclusion criteria (1 listed)
- Defective invasive arterial blood pressure monitoring
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 |
|---|---|---|
| Automated load-distributing band deviceAlso: AutoPulse™ 100, Zoll®Blood pressure recording before and after starting up the automated band device | Device | – |
Primary outcome
Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Time frame: Instantaneously
2 secondary outcomes
Systolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Time frame: Instantaneously
Mean blood pressures produced by manual and then by automated chest compressions will be recorded for each patient
Time frame: Instantaneously
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
Related trials for Cardiac Arrest
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
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Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
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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
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
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.
Francois-Xavier Duchateau, MD principal investigator
Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
Jean Mantz, MDPhD study chair
Departement of Anesthesiology, Intensive Care and EMS, Beaujon 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 Cardiac Arrest, run by Beaujon Hospital at 1 site in France.
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 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: finished, as of the sponsor's last update on 15 Jul 2009. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient (time frame: Instantaneously). 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 15 Jul 2009.