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Automated Chest Compression in Cardiac Arrest

This study has been completed.
Sponsor:
Information provided by:
Beaujon Hospital
ClinicalTrials.gov Identifier:
NCT00641069
First received: March 18, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Arrest
 Device: Automated load-distributing band device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Further study details as provided by Beaujon Hospital:

Primary Outcome Measures:
  • Diastolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic blood pressures produced by manual and then by automated chest compressions will be recorded for each patient [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]
  • Mean blood pressures produced by manual and then by automated chest compressions will be recorded for each patient [ Time Frame: Instantaneously ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Automated load-distributing band device
    Blood pressure recording before and after starting up the automated band device
    Other Name: AutoPulse™ 100, Zoll®
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients aged > 18 with out-of-hospital cardiac arrest

Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Refractory cardiac arrest

Exclusion Criteria:

  • Defective invasive arterial blood pressure monitoring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641069

Locations
France
Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
Clichy, France, 92110
Sponsors and Collaborators
Beaujon Hospital
Investigators
Principal Investigator: Francois-Xavier Duchateau, MD Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
Study Chair: Jean Mantz, MDPhD Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital
  More Information

No publications provided

Responsible Party: François-Xavier Duchateau, MD, Departement of Anesthesiology, Intensive Care and EMS, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT00641069     History of Changes
Other Study ID Numbers: BAND V6
Study First Received: March 18, 2008
Last Updated: July 14, 2009
Health Authority: France: Ministry of Health

Keywords provided by Beaujon Hospital:
Cardiac arrest
Cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013