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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00641069
Other study ID # BAND V6
Secondary ID
Status Completed
Phase N/A
First received March 18, 2008
Last updated July 14, 2009
Start date February 2008
Est. completion date January 2009

Study information

Verified date July 2009
Source Beaujon Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical 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.


Description:

The protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (AutoPulseā„¢ 100, ZollĀ®) 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18

- Refractory cardiac arrest

Exclusion Criteria:

- Defective invasive arterial blood pressure monitoring

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Automated load-distributing band device
Blood pressure recording before and after starting up the automated band device

Locations

Country Name City State
France Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital Clichy

Sponsors (1)

Lead Sponsor Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient Instantaneously No
Secondary Systolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient Instantaneously No
Secondary Mean blood pressures produced by manual and then by automated chest compressions will be recorded for each patient Instantaneously No
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