Cardiac Arrest, Out-Of-HospitalNCT04286204
New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial
A study testing Basic Life Support training based on ICTs and Classic Basic Life Support training in people with Cardiac Arrest, Out-Of-Hospital, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
With the increase in life expectancy of the general population and advances in medicine, there is now a population with a higher amount of cardiovascular diseases that lead to an increased risk of sudden cardiac arrest. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Basic Life Support training based on ICTs and Classic Basic Life Support training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2020to 1 Dec 2022
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Senior students over 14 years in high school.
Who cannot join
- Cognitive disorders.
- Cardiovascular o pulmonary diseases.
- Any condition that prevents physical activities.
- To have any previous training in basic life support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial.
With the increase in life expectancy of the general population and advances in medicine, there is now a population with a higher amount of cardiovascular diseases that lead to an increased risk of sudden cardiac arrest. In most cases, this occurs in extra-hospital settings such as family homes, shopping centres, public transport and before people without any knowledge or training in basic life support. On the other hand, for every minute that passes without adequate attention of the victim, the probability of surviving or continuing to live with neurological severe sequelae decreases by 10%.
In developed countries, public policies have been created to encourage basic life support education to the general population. In Colombia, because of the high prevalence of these diseases and the need for public health strategies, a law was issued to provide access to automatic external defibrillators (AEDs) in public places. However, it has not been developed strategies for education on this subject.
Read more
For that reason, the investigators created an educational strategy of self-learning, which consists of a complete basic life support course based in new Information and Communication technologies with tools to manufacture a mannequin and a homemade DEA, which will allow continuous training, with a very low cost compared to traditional life support training.
The clinical trial will compare that two educational strategies, evaluating as primary aid, which approach has higher knowledge retention of life support chain at 6 months in students after the workshop. As secondary objectives, the investigators would evaluate the efficient in terms of response times, costs and student satisfaction.
This study will be carried out in high school students from two different high schools, without prior training in Life support. Both strategies will be distributed randomly. The experimental group will carry out the self-learning strategy based on ICT (Information and Communication Technologies), with which they will be retrained every month, and the control group will carry out the conventional training only once as usual. Subsequently, each of the objectives will be evaluated at six months.
It is proposed that the self-learning strategy is superior compared to conventional training, requiring fewer resources to perform it and allows constant retraining, which improves retention and quality in a resuscitation process.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Basic Life Support training based on ICTs, Classic Basic Life Support training
- Keywords
- Cardiac Arrest, Basic Life Support, New Information and Communication Technologies
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Life Support training based on ICTsOther
This intervention is defined as a self-training course consisting of a 5-minute educational video in basic life support and a Kit with the elements to build the home dummy and the home DEA allowing integrally students to develop the steps as the video. The Kit will be delivered at the beginning of the study and every month the necessary materials will be complemented. The strategy will be carried out by the students every month and supervised by their teachers. Students will have constant access to an educational platform based on ICTs.
Classic Basic Life Support trainingOther
It is defined as a module carried out by trained personnel in basic resuscitation (pre-hospital care program staff of the UdeA medical school), which includes two subcomponents of the conventional BLS course that are basic resuscitation and DEA in adults. The duration of the subcomponents is a theoretical part of 30 minutes and a practical part in a low fidelity simulator with 1.5 hours duration.
| Study group | Role | What they receive |
|---|---|---|
| Basic Life Support Training based on ICTs | Experimental | It will be conformed with students from one highschool random selected. They will receive a basic life support training based on Information and communication technologies. Receives: Other: Basic Life Support training based on ICTs |
| Classic Basic Life Support Training | Active comparator | It will be conformed with students from another highschool random selected. They will receive a full and conventional basic life support training based on American and Hear Association recommendations. Receives: Other: Classic Basic Life Support training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality in survival chain in basic life support
It will be a composed outcome of 6 aspects in a check list and the student must comply ALL item to consider as a positive result in good quality in basic life support, the items are:
- Recognition of a person in cardiorespiratory arrest II. Activate the survival chain to survive III. Start chest compressions during or after activating the chain. IV. Chest compressions between 100-120 V. Proper use of AED VI. No interruptions should made during the thoracic compressions cycle. The result will be presented in proportion of students who completed ALL previous items.
Measured: 6 months
Secondary outcomes (3)
Time of survival chain activation
Time in seconds that takes the student to perform the following components of the survival chain:
- Identification of the victim
- Emergency system activation.
- Start of chest compressions.
- Implementation of the AED strategy.
Measured: 6 months
Student Satisfaction
The satisfaction scale will be applied to all students. We will use a satisfaction scale developed and validated in Oviedo´s University, Asturias, Spain. It is a seven items scale. Each item is evaluated in 4 points Likert scale. The minimum value is 1, and the maximum value is 4 for each item.
We will evaluate these scale independently and present results in number and percentage en each item.
Measured: 6 months
Costs
We will evaluate the cost in US dolar of each intervention in the different activities related to executions of the interventions in each arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: For COVID -19 pandemic, all participants (undergradueted students) can not completed the research protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Villa-Velasquez, Dr, Principal investigator, Univeridad de Antioquia's Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286204
- Sponsor's protocol ID
- SIIU 2019-28530
- Status last verified
- Apr 2021
- First submitted
- 13 Dec 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
PubMed 29386200Meissner TM, Kloppe C, Hanefeld C. Basic life support skills of high school students before and after cardiopulmonary resuscitation training: a longitudinal investigation. Scand J Trauma Resusc Emerg Med. 2012 Apr 14;20:31. doi: 10.1186/1757-7241-20-31.
PubMed 22502917Li Q, Zhou RH, Liu J, Lin J, Ma EL, Liang P, Shi TW, Fang LQ, Xiao H. Pre-training evaluation and feedback improved skills retention of basic life support in medical students. Resuscitation. 2013 Sep;84(9):1274-8. doi: 10.1016/j.resuscitation.2013.04.017. Epub 2013 May 9.
PubMed 23665155Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.
PubMed 22080629Smith KK, Gilcreast D, Pierce K. Evaluation of staff's retention of ACLS and BLS skills. Resuscitation. 2008 Jul;78(1):59-65. doi: 10.1016/j.resuscitation.2008.02.007. Epub 2008 Apr 10.
PubMed 18406037de Ruijter PA, Biersteker HA, Biert J, van Goor H, Tan EC. Retention of first aid and basic life support skills in undergraduate medical students. Med Educ Online. 2014 Nov 6;19:24841. doi: 10.3402/meo.v19.24841. eCollection 2014.
PubMed 25382803Pande S, Pande S, Parate V, Pande S, Sukhsohale N. Evaluation of retention of knowledge and skills imparted to first-year medical students through basic life support training. Adv Physiol Educ. 2014 Mar;38(1):42-5. doi: 10.1152/advan.00102.2013.
PubMed 24585468Einspruch EL, Lynch B, Aufderheide TP, Nichol G, Becker L. Retention of CPR skills learned in a traditional AHA Heartsaver course versus 30-min video self-training: a controlled randomized study. Resuscitation. 2007 Sep;74(3):476-86. doi: 10.1016/j.resuscitation.2007.01.030. Epub 2007 Apr 17.
PubMed 17442479Girish M, Rawekar A, Jose S, Chaudhari U, Nanoti G. Utility of Low Fidelity Manikins for Learning High Quality Chest Compressions. Indian J Pediatr. 2018 Mar;85(3):184-188. doi: 10.1007/s12098-017-2473-3. Epub 2017 Nov 20.
PubMed 29152687Jones I, Whitfield R, Colquhoun M, Chamberlain D, Vetter N, Newcombe R. At what age can schoolchildren provide effective chest compressions? An observational study from the Heartstart UK schools training programme. BMJ. 2007 Jun 9;334(7605):1201. doi: 10.1136/bmj.39167.459028.DE. Epub 2007 Apr 27.
PubMed 17468118Boet S, Bould MD, Pigford AA, Rossler B, Nambyiah P, Li Q, Bunting A, Schebesta K. Retention of Basic Life Support in Laypeople: Mastery Learning vs. Time-based Education. Prehosp Emerg Care. 2017 May-Jun;21(3):362-377. doi: 10.1080/10903127.2016.1258096. Epub 2017 Jan 6.
PubMed 28059603Pedersen TH, Kasper N, Roman H, Egloff M, Marx D, Abegglen S, Greif R. Self-learning basic life support: A randomised controlled trial on learning conditions. Resuscitation. 2018 May;126:147-153. doi: 10.1016/j.resuscitation.2018.02.031. Epub 2018 Mar 6.
PubMed 29522830Kanstad BK, Nilsen SA, Fredriksen K. CPR knowledge and attitude to performing bystander CPR among secondary school students in Norway. Resuscitation. 2011 Aug;82(8):1053-9. doi: 10.1016/j.resuscitation.2011.03.033. Epub 2011 Apr 13.
PubMed 21531067
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial.
- ClinicalTrials.gov ID
- NCT04286204
- Acronym / sponsor ID
- SIIU 2019-28530
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- Cardiac Arrest, Basic Life Support, New Information and Communication Technologies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: For COVID -19 pandemic, all participants (undergradueted students) can not completed the research protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Feb 2020 (actual)
- 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.
With the increase in life expectancy of the general population and advances in medicine, there is now a population with a higher amount of cardiovascular diseases that lead to an increased risk of sudden cardiac arrest. In most cases, this occurs in extra-hospital settings such as family homes, shopping centres, public transport and before people without any knowledge or training in basic life support. On the other hand, for every minute that passes without adequate attention of the victim, the probability of surviving or continuing to live with neurological severe sequelae decreases by 10%.
In developed countries, public policies have been created to encourage basic life support education to the general population. In Colombia, because of the high prevalence of these diseases and the need for public health strategies, a law was issued to provide access to automatic external defibrillators (AEDs) in public places. However, it has not been developed strategies for education on this subject.
For that reason, the investigators created an educational strategy of self-learning, which consists of a complete basic life support course based in new Information and Communication technologies with tools to manufacture a mannequin and a homemade DEA, which will allow continuous training, with a very low cost compared to traditional life support training.
The clinical trial will compare that two educational strategies, evaluating as primary aid, which approach has higher knowledge retention of life support chain at 6 months in students after the workshop. As secondary objectives, the investigators would evaluate the efficient in terms of response times, costs and student satisfaction.
This study will be carried out in high school students from two different high schools, without prior training in Life support. Both strategies will be distributed randomly. The experimental group will carry out the self-learning strategy based on ICT (Information and Communication Technologies), with which they will be retrained every month, and the control group will carry out the conventional training only once as usual. Subsequently, each of the objectives will be evaluated at six months.
It is proposed that the self-learning strategy is superior compared to conventional training, requiring fewer resources to perform it and allows constant retraining, which improves retention and quality in a resuscitation process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Life Support Training based on ICTs | Experimental | Other: Basic Life Support training based on ICTsIt will be conformed with students from one highschool random selected. They will receive a basic life support training based on Information and communication technologies. |
| Classic Basic Life Support Training | Active comparator | Other: Classic Basic Life Support trainingIt will be conformed with students from another highschool random selected. They will receive a full and conventional basic life support training based on American and Hear Association recommendations. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Senior students over 14 years in high school.
Key exclusion criteria (4 listed)
- Cognitive disorders.
- Cardiovascular o pulmonary diseases.
- Any condition that prevents physical activities.
- To have any previous training in basic life support.
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 |
|---|---|---|
| Basic Life Support training based on ICTsThis intervention is defined as a self-training course consisting of a 5-minute educational video in basic life support and a Kit with the elements to build the home dummy and the home DEA allowing integrally students to develop the steps as the video. The Kit will be delivered at the beginning of the study and every month the necessary materials will be complemented. The strategy will be carried out by the students every month and supervised by their teachers. Students will have constant access to an educational platform based on ICTs. | Other | Basic Life Support Training based on ICTs |
| Classic Basic Life Support trainingIt is defined as a module carried out by trained personnel in basic resuscitation (pre-hospital care program staff of the UdeA medical school), which includes two subcomponents of the conventional BLS course that are basic resuscitation and DEA in adults. The duration of the subcomponents is a theoretical part of 30 minutes and a practical part in a low fidelity simulator with 1.5 hours duration. | Other | Classic Basic Life Support Training |
Primary outcome
Quality in survival chain in basic life support
Time frame: 6 months
It will be a composed outcome of 6 aspects in a check list and the student must comply ALL item to consider as a positive result in good quality in basic life support, the items are: I. Recognition of a person in cardiorespiratory arrest II. Activate the survival chain to survive III. Start chest compressions during or after activating the chain. IV. Chest compressions between 100-120 V. Proper use of AED VI. No interruptions should made during the thoracic compressions cycle. The result will be presented in proportion of students who completed ALL previous items.
3 secondary outcomes
Time of survival chain activation
Time frame: 6 months
Student Satisfaction
Time frame: 6 months
Costs
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 29386200Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Results publication: PubMed 22502917Meissner TM, Kloppe C, Hanefeld C. Basic life support skills of high school students before and after cardiopulmonary resuscitation training: a longitudinal investigation. Scand J Trauma Resusc Emerg Med. 2012 Apr 14;20:31. doi: 10.1186/1757-7241-20-31.
- Results publication: PubMed 23665155Li Q, Zhou RH, Liu J, Lin J, Ma EL, Liang P, Shi TW, Fang LQ, Xiao H. Pre-training evaluation and feedback improved skills retention of basic life support in medical students. Resuscitation. 2013 Sep;84(9):1274-8. doi: 10.1016/j.resuscitation.2013.04.017. Epub 2013 May 9.
- Results publication: PubMed 22080629Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.
- Results publication: PubMed 18406037Smith KK, Gilcreast D, Pierce K. Evaluation of staff's retention of ACLS and BLS skills. Resuscitation. 2008 Jul;78(1):59-65. doi: 10.1016/j.resuscitation.2008.02.007. Epub 2008 Apr 10.
- Results publication: PubMed 25382803de Ruijter PA, Biersteker HA, Biert J, van Goor H, Tan EC. Retention of first aid and basic life support skills in undergraduate medical students. Med Educ Online. 2014 Nov 6;19:24841. doi: 10.3402/meo.v19.24841. eCollection 2014.
- Results publication: PubMed 24585468Pande S, Pande S, Parate V, Pande S, Sukhsohale N. Evaluation of retention of knowledge and skills imparted to first-year medical students through basic life support training. Adv Physiol Educ. 2014 Mar;38(1):42-5. doi: 10.1152/advan.00102.2013.
- Results publication: PubMed 17442479Einspruch EL, Lynch B, Aufderheide TP, Nichol G, Becker L. Retention of CPR skills learned in a traditional AHA Heartsaver course versus 30-min video self-training: a controlled randomized study. Resuscitation. 2007 Sep;74(3):476-86. doi: 10.1016/j.resuscitation.2007.01.030. Epub 2007 Apr 17.
- Results publication: PubMed 29152687Girish M, Rawekar A, Jose S, Chaudhari U, Nanoti G. Utility of Low Fidelity Manikins for Learning High Quality Chest Compressions. Indian J Pediatr. 2018 Mar;85(3):184-188. doi: 10.1007/s12098-017-2473-3. Epub 2017 Nov 20.
- Results publication: PubMed 17468118Jones I, Whitfield R, Colquhoun M, Chamberlain D, Vetter N, Newcombe R. At what age can schoolchildren provide effective chest compressions? An observational study from the Heartstart UK schools training programme. BMJ. 2007 Jun 9;334(7605):1201. doi: 10.1136/bmj.39167.459028.DE. Epub 2007 Apr 27.
- Results publication: PubMed 28059603Boet S, Bould MD, Pigford AA, Rossler B, Nambyiah P, Li Q, Bunting A, Schebesta K. Retention of Basic Life Support in Laypeople: Mastery Learning vs. Time-based Education. Prehosp Emerg Care. 2017 May-Jun;21(3):362-377. doi: 10.1080/10903127.2016.1258096. Epub 2017 Jan 6.
- Results publication: PubMed 29522830Pedersen TH, Kasper N, Roman H, Egloff M, Marx D, Abegglen S, Greif R. Self-learning basic life support: A randomised controlled trial on learning conditions. Resuscitation. 2018 May;126:147-153. doi: 10.1016/j.resuscitation.2018.02.031. Epub 2018 Mar 6.
- Individual participant dataSharing planned: No
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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.
Juan Villa-Velasquez, Dr principal investigator
Univeridad de Antioquia's Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Life Support training based on ICTs and Classic Basic Life Support training in people with Cardiac Arrest, Out-Of-Hospital, run by Universidad de Antioquia at 1 site in Colombia.
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 4 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: withdrawn, as of the sponsor's last update on 9 May 2024. 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 Colombia. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality in survival chain in basic life support (time frame: 6 months). 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 NCT04286204, which also lists 13 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 9 May 2024.