NCT01952197

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,130

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

September 13, 2013

Last Update Submit

September 3, 2014

Conditions

Heart Arrest

Keywords

Passive Leg RaiseCardiac arrestSurvival after CPR

Outcome Measures

Primary Outcomes (1)

  • Increase the Effect of Chest Compressions in cpr

    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.

    up to 5 min

Secondary Outcomes (3)

  • Survival to hospital admission after ROSC

    24 hours

  • Survival to one month after ROSC

    one month

  • Survival to one year

    one year

Study Arms (1)

Passive Leg Raise

EXPERIMENTAL

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

Interventions

Passive Leg RaiseOTHER

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.

Also known as: PLR
Passive Leg Raise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac arrest where the rescue team perform chest compression.

You may not qualify if:

  • Persons under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departament of Nursing. Universitat Rovira i Virgili.

Tarragona, Tarragona, 43007, Spain

RECRUITING

Related Publications (4)

  • Axelsson C, Holmberg S, Karlsson T, Axelsson AB, Herlitz J. Passive leg raising during cardiopulmonary resuscitation in out-of-hospital cardiac arrest--does it improve circulation and outcome? Resuscitation. 2010 Dec;81(12):1615-20. doi: 10.1016/j.resuscitation.2010.08.019. Epub 2010 Sep 16.

    PMID: 20843594BACKGROUND

  • Dragoumanos V, Iacovidou N, Chalkias A, Lelovas P, Koutsovasilis A, Papalois A, Xanthos T. Passive leg raising during cardiopulmonary resuscitation results in improved neurological outcome in a swine model of prolonged ventricular fibrillation. Am J Emerg Med. 2012 Nov;30(9):1935-42. doi: 10.1016/j.ajem.2012.04.014. Epub 2012 Jul 12.

    PMID: 22795422BACKGROUND

  • Jimenez-Herrera MF, Azeli Y, Valero-Mora E, Lucas-Guarque I, Lopez-Gomariz A, Castro-Naval E, Axelsson C. Passive leg raise (PLR) during cardiopulmonary (CPR) - a method article on a randomised study of survival in out-of-hospital cardiac arrest (OHCA). BMC Emerg Med. 2014 Jul 4;14:15. doi: 10.1186/1471-227X-14-15.

    PMID: 24993861BACKGROUND

  • Azeli Y, Bardaji A, Barberia E, Lopez-Madrid V, Blade-Creixenti J, Fernandez-Sender L, Bonet G, Rica E, Alvarez S, Fernandez A, Axelsson C, Jimenez-Herrera MF. Clinical outcomes and safety of passive leg raising in out-of-hospital cardiac arrest: a randomized controlled trial. Crit Care. 2021 May 25;25(1):176. doi: 10.1186/s13054-021-03593-7.

    PMID: 34034775DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Maria Jiménez, phD

    Universitat Rovira i Virgili. Tarragona. Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Jimenez, phD

CONTACT

+34609960648maria.jimenez@urv.cat

Christer Axelsson, phD

CONTACT

+46705400304christer.axelsson@hb.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jiménez Herrera

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 27, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations

ES(1)