Heart ArrestEP-PCEHNCT01952197
Passive Leg Raise (PLR) During Cardiopulmonary Resuscitation (CPR)
A study testing Passive Leg Raise in people with Heart Arrest, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Passive Leg Raise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,130 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- Cardiac arrest where the rescue team perform chest compression.
Who cannot join
- Persons under 18 years
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Departament of Nursing. Universitat Rovira i Virgili.
Tarragona, Tarragona, 43007
Maria Jimenez, phD, +34977299418, maria.jimenez@urv.cat
Christer Axelsson, phD
About this study
Official title: Passive Leg Raise (PLR) During Cardiopulmonary Resuscitation (CPR): a Randomised Study of Survival in Out-of-hospital Cardiac Arrest (OHCA)
- 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.
Read the detailed description
- Background The majority of sudden death cases have a cardiac origin and occur unexpectedly, often outside hospital. Attwood et al.[1] estimated the incidence of and survival from EMS-treated OHCA in Europe and found, for "all-rhythm" CA, an incidence of 37.72 per 100,000 person-years. Survival was 10.7% in "all-rhythm" CA. If these results were applied to the European population, approximately 275,000 persons would experience an all-rhythm, EMS-treated OHCA, with 29,000 persons surviving to hospital discharge[1]. To resuscitate a person, without neurological damage, various efforts, which are described as the four links in the chain of survival (early call, early CPR, early defibrillation and early advanced life support), have to be optimal[2]. During the last decade, the quality and continuity of chest compressions have been increasingly highlighted[3]. The reason is that blood flow and coronary perfusion during cardiac arrest are related to the quality and continuity of chest compressions[4]. A coronary perfusion pressure (CPP) above 15mmHg, at defibrillation, also appears to be necessary for the return of spontaneous circulation (ROSC)[5]. Consequently, different methods and devices to improve blood flow to the heart (coronary perfusion) and brain during CPR, such as different types of mechanical compressor and impedance threshold device[6-9], have been studied. The initial CPR guidelines[10-12] stated that the "elevation of the lower extremities may promote venous return and augment artificial circulation during external cardiac compression". However, in the 1992 guidelines[13], this statement was removed. The reason for this decision was a lack of clinical evidence. During the last five years, the debate on how PLR may improve the outcomes of the resuscitation manoeuvres in CPR has been re-opened. According to Préau et al.[14], the effect of PLR is equivalent to a rapid intravenous volume expander by shifting blood from the lower extremities towards the intra-thoracic compartment. A 45° leg elevation for four minutes increases right and left ventricular preload and, by definition, the stroke volume, if the heart is preload dependent[15]. This makes PLR predictive of fluid responsiveness among patients with circulatory failure, e.g. sepsis and acute pancreatitis[14-17], and it has been recommended as part of haemodynamic monitoring in recent international recommendations[18]. Other researchers have also shown the benefit of using PLR to increase resistance to blood flow[19], thereby shifting fluid from the lower extremities to the central circulation[20, 21]. The present study design is based on a pilot study recently conducted in Gothenburg, Sweden. This pilot study concluded that a 20° leg elevation during CPR improved the levels of end-tidal carbon dioxide (EtCO2) during CPR[22]. It has previously been concluded that EtCO2 correlates well with blood flow and that PLR induces an increase in descending aortic blood flow of at least 10% or in echocardiographic sub-aortic flow of at least 12%[23-26]. In other studies, EtCO2 has been shown to be quantitatively predictive of stroke volumes[27]. EtCO2 has also been described as an important value for predicting ROSC and CPR quality[22, 28, 29]. The resuscitation in the Gothenburg pilot study was performed using both manual and mechanical compressions made by LUCAS TM 2 (Lund University Cardiac Assist System), but the effect of PLR appeared to be greater during manual compressions. It was only possible to speculate on the reason for this, but the EtCO2 value started from a higher level in the mechanical group. The possible reason for this could be the "active decompression" creating a larger preload. Dragoumanos et al.[30] found in their animal study that the coronary perfusion pressure (CPP) also increased when PLR was performed during CPR and auto-transfusion of the aorta by PLR was the explanation. It is unclear whether this mechanism can be transferred to humans. The literature also includes some case reports and letters advocating PLR during CPR[31, 32]. However, no studies showing that PLR during CPR will increase survival have been conducted.
- Method and design: A prospective, randomised, controlled trial in which all patients (>18 years) receiving out-of hospital CPR are randomised by envelope to be treated with either PLR or in a flat position. The ambulance crew use a special folding stool, which allows the legs to be elevated about 20 degrees. The PLR manoeuvre needs to be performed immediately (within five minutes) after the arrival of the first ambulance. Leg elevation has to be maintained while the patient receives chest compressions during CPR and has to be stopped when the patient has an ROSC or when a medical decision is made to interrupt these manoeuvres. PLR is to be performed at an angle of between 20 and 45 degrees (approximately 35 to 40 cm). An instruction video is produced for training prior to the study; the aim of using a specially designed folding stool is to standardise the intervention as much as possible. In the start-up phase between June 2013 and April 2014, the study has only been conducted in the City of Tarragona and the surrounding areas. In all, 13 mobile units (12 BLS and one ALS unit) will attend (attended) in the start-up phase. Since April 2014, a further 56 units, the whole province, have been participating in the study. The study will continue for three years.
- Patient selection and randomization: Inclusion/exclusion Inclusion: All patients of both sexes who suffer an out-of-hospital cardiorespiratory arrest and require CPR and who are attended by the BLS and/or ALS units in the Tarragona area. Exclusion: Patients aged < 18 will be excluded from the study. Allocation concealment is ensured via opaque, numbered and sealed envelopes. The random allocation lists are generated by a web-based automated randomization system. To guarantee a numeric balance across conditions the randomisation will be performed separately in random permuted blocks of hundred. The allocation list will be kept in a remote secure location and an independent person randomly allocates the envelopes.
- Endpoints: Primary end-point: survival to one month Secondary end-point: survival to hospital admission to one month and to one year with acceptable cerebral performance classification (CPC) 1-2 [33]
- Evaluation of other result: Sub-group analysis: the result will also be analysed in relation to rhythm (shockable/non- shockable rhythm), age (more and less than 65 years), gender and ambulance delay (more and less than 10 minutes). Statistical analysis Group comparisons (PLR/flat position) will be performed using Fisher's non-parametric permutation test, the Mann-Whitney U test for continuous/ordered variables and Fisher's exact test for dichotomous variables. All tests will be two-tailed and p-values below 0.05 will be considered statistically significant.
- Study time: April 1, 2012 -Mars 31 2015 (Sweden) Jun 8, 2013 - Jun 2016 (Catalonia)
- Conditions
- Heart Arrest
- Being tested
- Passive Leg Raise
- Keywords
- Passive Leg Raise, Cardiac arrest, Survival after CPR
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaiseOther
Also called PLR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Passive Leg Raise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 min
Secondary outcomes (3)
Survival to hospital admission after ROSC
Know the survival after arrived to the hospital after ROSC
Measured: 24 hours
Survival to one month after ROSC
Know the survival to one month
Measured: one month
Survival to one year
Know survivals to one year and what is the cerebral function (CPC-score 1, 2).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Cataluña, Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Principal investigator, Maria F. Jimenez Herrera, University Rovira i Virgili
- Investigators
- Maria Jiménez, phD, Principal investigator, Universitat Rovira i Virgili. Tarragona. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952197
- Sponsor's protocol ID
- EP-PCEH-2013
- Acronym
- EP-PCEH
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20843594Dragoumanos 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.
PubMed 22795422Jimenez-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.
PubMed 24993861Azeli 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.
PubMed 34034775
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Leg Raise (PLR) During Cardiopulmonary Resuscitation (CPR): a Randomised Study of Survival in Out-of-hospital Cardiac Arrest (OHCA)
- ClinicalTrials.gov ID
- NCT01952197
- Acronym / sponsor ID
- EP-PCEH / EP-PCEH-2013
- Conditions
- Heart Arrest
- Keywords
- Passive Leg Raise, Cardiac arrest, Survival after CPR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,130 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Public Health Service of Cataluña, Hospital Universitari Joan XXIII de Tarragona.
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Sep 2013 (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.
- 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.
Detailed description
- Background The majority of sudden death cases have a cardiac origin and occur unexpectedly, often outside hospital. Attwood et al.[1] estimated the incidence of and survival from EMS-treated OHCA in Europe and found, for "all-rhythm" CA, an incidence of 37.72 per 100,000 person-years. Survival was 10.7% in "all-rhythm" CA. If these results were applied to the European population, approximately 275,000 persons would experience an all-rhythm, EMS-treated OHCA, with 29,000 persons surviving to hospital discharge[1]. To resuscitate a person, without neurological damage, various efforts, which are described as the four links in the chain of survival (early call, early CPR, early defibrillation and early advanced life support), have to be optimal[2]. During the last decade, the quality and continuity of chest compressions have been increasingly highlighted[3]. The reason is that blood flow and coronary perfusion during cardiac arrest are related to the quality and continuity of chest compressions[4]. A coronary perfusion pressure (CPP) above 15mmHg, at defibrillation, also appears to be necessary for the return of spontaneous circulation (ROSC)[5]. Consequently, different methods and devices to improve blood flow to the heart (coronary perfusion) and brain during CPR, such as different types of mechanical compressor and impedance threshold device[6-9], have been studied. The initial CPR guidelines[10-12] stated that the "elevation of the lower extremities may promote venous return and augment artificial circulation during external cardiac compression". However, in the 1992 guidelines[13], this statement was removed. The reason for this decision was a lack of clinical evidence. During the last five years, the debate on how PLR may improve the outcomes of the resuscitation manoeuvres in CPR has been re-opened. According to Préau et al.[14], the effect of PLR is equivalent to a rapid intravenous volume expander by shifting blood from the lower extremities towards the intra-thoracic compartment. A 45° leg elevation for four minutes increases right and left ventricular preload and, by definition, the stroke volume, if the heart is preload dependent[15]. This makes PLR predictive of fluid responsiveness among patients with circulatory failure, e.g. sepsis and acute pancreatitis[14-17], and it has been recommended as part of haemodynamic monitoring in recent international recommendations[18]. Other researchers have also shown the benefit of using PLR to increase resistance to blood flow[19], thereby shifting fluid from the lower extremities to the central circulation[20, 21]. The present study design is based on a pilot study recently conducted in Gothenburg, Sweden. This pilot study concluded that a 20° leg elevation during CPR improved the levels of end-tidal carbon dioxide (EtCO2) during CPR[22]. It has previously been concluded that EtCO2 correlates well with blood flow and that PLR induces an increase in descending aortic blood flow of at least 10% or in echocardiographic sub-aortic flow of at least 12%[23-26]. In other studies, EtCO2 has been shown to be quantitatively predictive of stroke volumes[27]. EtCO2 has also been described as an important value for predicting ROSC and CPR quality[22, 28, 29]. The resuscitation in the Gothenburg pilot study was performed using both manual and mechanical compressions made by LUCAS TM 2 (Lund University Cardiac Assist System), but the effect of PLR appeared to be greater during manual compressions. It was only possible to speculate on the reason for this, but the EtCO2 value started from a higher level in the mechanical group. The possible reason for this could be the "active decompression" creating a larger preload. Dragoumanos et al.[30] found in their animal study that the coronary perfusion pressure (CPP) also increased when PLR was performed during CPR and auto-transfusion of the aorta by PLR was the explanation. It is unclear whether this mechanism can be transferred to humans. The literature also includes some case reports and letters advocating PLR during CPR[31, 32]. However, no studies showing that PLR during CPR will increase survival have been conducted.
- Method and design: A prospective, randomised, controlled trial in which all patients (>18 years) receiving out-of hospital CPR are randomised by envelope to be treated with either PLR or in a flat position. The ambulance crew use a special folding stool, which allows the legs to be elevated about 20 degrees. The PLR manoeuvre needs to be performed immediately (within five minutes) after the arrival of the first ambulance. Leg elevation has to be maintained while the patient receives chest compressions during CPR and has to be stopped when the patient has an ROSC or when a medical decision is made to interrupt these manoeuvres. PLR is to be performed at an angle of between 20 and 45 degrees (approximately 35 to 40 cm). An instruction video is produced for training prior to the study; the aim of using a specially designed folding stool is to standardise the intervention as much as possible. In the start-up phase between June 2013 and April 2014, the study has only been conducted in the City of Tarragona and the surrounding areas. In all, 13 mobile units (12 BLS and one ALS unit) will attend (attended) in the start-up phase. Since April 2014, a further 56 units, the whole province, have been participating in the study. The study will continue for three years.
- Patient selection and randomization: Inclusion/exclusion Inclusion: All patients of both sexes who suffer an out-of-hospital cardiorespiratory arrest and require CPR and who are attended by the BLS and/or ALS units in the Tarragona area. Exclusion: Patients aged < 18 will be excluded from the study. Allocation concealment is ensured via opaque, numbered and sealed envelopes. The random allocation lists are generated by a web-based automated randomization system. To guarantee a numeric balance across conditions the randomisation will be performed separately in random permuted blocks of hundred. The allocation list will be kept in a remote secure location and an independent person randomly allocates the envelopes.
- Endpoints: Primary end-point: survival to one month Secondary end-point: survival to hospital admission to one month and to one year with acceptable cerebral performance classification (CPC) 1-2 [33]
- Evaluation of other result: Sub-group analysis: the result will also be analysed in relation to rhythm (shockable/non- shockable rhythm), age (more and less than 65 years), gender and ambulance delay (more and less than 10 minutes). Statistical analysis Group comparisons (PLR/flat position) will be performed using Fisher's non-parametric permutation test, the Mann-Whitney U test for continuous/ordered variables and Fisher's exact test for dichotomous variables. All tests will be two-tailed and p-values below 0.05 will be considered statistically significant.
- Study time: April 1, 2012 -Mars 31 2015 (Sweden) Jun 8, 2013 - Jun 2016 (Catalonia)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive Leg Raise | Experimental | Other: Passive Leg RaiseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac arrest where the rescue team perform chest compression.
Key exclusion criteria (1 listed)
- Persons under 18 years
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 |
|---|---|---|
| Passive Leg RaiseAlso: PLRThe 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 |
Primary outcome
Increase the Effect of Chest Compressions in cpr
Time frame: up to 5 min
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.
3 secondary outcomes
Survival to hospital admission after ROSC
Time frame: 24 hours
Survival to one month after ROSC
Time frame: one month
Survival to one year
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- Background: PubMed 20843594Axelsson 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.
- Background: PubMed 22795422Dragoumanos 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.
- Background: PubMed 24993861Jimenez-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.
- Derived from this study: PubMed 34034775Azeli 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.
- Method articleLink provided by the sponsor.
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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.
Maria Jiménez, phD principal investigator
Universitat Rovira i Virgili. Tarragona. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raise in people with Heart Arrest, run by University Rovira i Virgili at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Sep 2014. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jimenez, phD (+34609960648, maria.jimenez@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase the Effect of Chest Compressions in cpr (time frame: up to 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952197, which also lists 4 linked publications.
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 4 Sep 2014.