Passive Leg Raise (PLR) During Cardiopulmonary Resuscitation (CPR) (EP-PCEH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Rovira i Virgili
Sponsor:
Collaborators:
Public Health Service of Cataluña
Hospital Universitari Joan XXIII de Tarragona.
Information provided by (Responsible Party):
Maria F. Jimenez Herrera, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT01952197
First received: September 13, 2013
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

1. Hypothesis The early elevation of the lower extremities during out-of-hospital cardiopulmonary resuscitation increases survival to one month by improving cardiac preload and blood flow to the heart and brain during chest compression.


Condition Intervention
Heart Arrest
Other: Passive Leg Raise

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Passive Leg Raise (PLR) During Cardiopulmonary Resuscitation (CPR): a Randomised Study of Survival in Out-of-hospital Cardiac Arrest (OHCA)

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Increase the Effect of Chest Compressions in cpr [ Time Frame: up to 5 min ] [ Designated as safety issue: No ]
    The leg raise is performed during the first minutes of CPR (limit 5 min) and will continue as long as the patients receive chest compression. In Spain the patient is immediate randomized by envelope. If the patient is randomized to PLR, the ambulance crews use a special folding stool that allows the legs to be raised about 20 degrees.


Secondary Outcome Measures:
  • Survival to hospital admission after ROSC [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Know the survival after arrived to the hospital after ROSC

  • Survival to one month after ROSC [ Time Frame: one month ] [ Designated as safety issue: No ]
    Know the survival to one month

  • Survival to one year [ Time Frame: one year ] [ Designated as safety issue: No ]
    Know survivals to one year and what is the cerebral function (CPC-score 1, 2).


Estimated Enrollment: 3130
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Passive Leg Raise
The intervention is made on all adult patients receiving CPR by the ambulance crew. The leg raise is performed during the first minutes of CPR (limit 5 min) and will continue as long as the patients receive chest compression. In Spain the patient is immediate randomized by envelope. If the patient is randomized to PLR, the ambulance crews use a special folding stool that allows the legs to be raised about 20 degrees.
Other: Passive Leg Raise
The intervention is made on all adult patients receiving CPR by the ambulance crew. The leg raise is performed during the first minutes of CPR (limit 5 min) and will continue as long as the patients receive chest compression. In Spain the patient is immediate randomized by envelope. If the patient is randomized to PLR, the ambulance crews use a special folding stool that allows the legs to be raised about 20 degrees.
Other Name: PLR

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac arrest where the rescue team perform chest compression.

Exclusion Criteria:

  • Persons under 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952197

Contacts
Contact: Maria Jimenez, phD +34609960648 maria.jimenez@urv.cat
Contact: Christer Axelsson, phD +46705400304 christer.axelsson@hb.se

Locations
Spain
Departament of Nursing. Universitat Rovira i Virgili. Recruiting
Tarragona, Spain, 43007
Contact: Maria Jimenez, phD    +34977299418    maria.jimenez@urv.cat   
Principal Investigator: Christer Axelsson, phD         
Sponsors and Collaborators
University Rovira i Virgili
Public Health Service of Cataluña
Hospital Universitari Joan XXIII de Tarragona.
Investigators
Principal Investigator: Maria Jiménez, phD Universitat Rovira i Virgili. Tarragona. Spain
  More Information

Additional Information:
No publications provided by University Rovira i Virgili

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria F. Jimenez Herrera, Dr. Jiménez Herrera, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT01952197     History of Changes
Other Study ID Numbers: EP-PCEH-2013
Study First Received: September 13, 2013
Last Updated: September 3, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by University Rovira i Virgili:
Passive Leg Raise
Cardiac arrest
Survival after CPR

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 28, 2014