An interventional study of BLS and AED Training With Rescue Breaths and BLS and AED Training Without Rescue Breaths in Cardiopulmonary Resuscitation and Out-of-Hospital Cardiac Arrest, sponsored by Universitat Internacional de Catalunya. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Other
Survival after out-of-hospital cardiac arrest rarely exceeds 10%, and cardiopulmonary resuscitation (CPR) started by bystanders is a key factor for survival. Rescue breaths can be a technical and emotional barrier for lay rescuers and are often performed incorrectly, which has led to questioning whether they should be taught in initial basic life support (BLS) training for lay people.
This randomized study compares two BLS and automated external defibrillator (AED) training methods in first-year nursing students at the Universitat Internacional de Catalunya, a population chosen for its similarity to lay first responders. The control group will be trained following the traditional algorithm with chest compressions and mouth-to-mouth rescue breaths (30:2). The intervention group will be trained following a simplified model based only on continuous chest compressions, without rescue breaths.
After training, each participant will complete a theoretical test and an individual simulated cardiac arrest scenario with 8 minutes of uninterrupted CPR on a high-fidelity manikin. Theoretical-practical competence, CPR quality and rescuer fatigue (muscular, cardiovascular and perceived) will be assessed. Competence will be reassessed 4 months later to evaluate retention.
The hypothesis is that BLS and AED training without mouth-to-mouth rescue breaths improves theoretical-practical competence and its retention at 4 months compared with the traditional method during 8 minutes of CPR in lay people.
Design and setting: randomized experimental study with two parallel groups, conducted at the Centro Integral de Simulación Avanzada (CISA) of the Universitat Internacional de Catalunya (UIC), Sant Cugat del Vallès (Barcelona, Spain), following CONSORT recommendations.
Population and allocation: first-year nursing degree students at UIC. After an information session and written informed consent, participants will be randomly allocated into two groups of equal size: the control group (CG) or the intervention group (IG). Staff responsible for recruitment will not have access to the randomization sequence. To maintain participant blinding, participants will be informed beforehand that they will receive different training modalities and that they must apply the content learned in the initial and 4-month follow-up assessments.
Sample size: calculated with G*Power (effect size d = 0.59, derived from a previous study in the same population and institution; alpha = 0.05; two-sided test; power 80%): 47 participants per group; allowing for 10% losses, 52 participants per group (104 in total) will be enrolled.
Interventions: both groups will receive BLS and AED training delivered by official European Resuscitation Council (ERC) instructors. Instructors will be assigned to one of the two training models (with or without rescue breaths). CG: BLS and AED training with traditional CPR (30 chest compressions and 2 mouth-to-mouth rescue breaths). IG: BLS and AED training with continuous chest compressions without mouth-to-mouth rescue breaths.
Procedures: before training, participants will complete a sociodemographic questionnaire, a physical activity questionnaire (IPAQ-SF) and a questionnaire on self-perceived BLS and AED knowledge. After training, participants will complete the final theoretical test (10 multiple-choice questions from the Catalan Resuscitation Council) and an individual practical assessment: an identical clinical case for both groups with 8 minutes of uninterrupted CPR on a Resusci Anne QCPR manikin (Laerdal) connected to SkillReporter software. CPR quality data will be recorded continuously and every 2 minutes (2, 4, 6 and 8 minutes). Practical performance will be rated by the instructor using the CORVAL rubric. Before and immediately after the simulation, perceived exertion (modified Borg scale), muscular fatigue (dynamometer: sustained 20-second contraction of a hand-held pneumatic bulb, with software recording the force curve), blood pressure and heart rate (blood pressure monitor) and peripheral oxygen saturation (non-invasive finger pulse oximeter, outside the CPR period) will be measured; heart rate will also be recorded continuously during the simulation with an arm heart rate monitor. Self-perceived knowledge will be assessed again after the simulation, and participants will complete a satisfaction survey. Manikins of the same model will be used; their use will be documented and they will be randomly assigned. Before the intervention, a pilot test with the same characteristics will be carried out to ensure feasibility, correct application of the measurement instruments and standardisation of the simulation conditions.
Retention: 4 months after training, before the retention assessment, participants will complete a second sociodemographic questionnaire, including CPR training received during the study. The theoretical and practical assessment will then be repeated following the same procedure, without fatigue measurements. After the assessment, the self-perceived knowledge questionnaire will be administered again.
Statistical analysis: quantitative variables will be described as mean and standard deviation or median and interquartile range, according to normality (Kolmogorov-Smirnov test). Between-group comparisons will use Student's t test or Mann-Whitney U test, and chi-square (with Yates correction) or Fisher's exact test for categorical variables. Multivariable logistic regression (enter method) will be used to identify factors associated with competence, retention and rescuer fatigue, including type of training and sociodemographic variables. Pearson or Spearman correlation will be used according to normality. Retention at 4 months will be analysed with the same tests and, when appropriate, with paired t test or Wilcoxon test. A p value \< 0.05 will be considered statistically significant, and 95% confidence intervals will be calculated for measures of association (odds ratios or mean differences). Analyses will be performed with IBM SPSS Statistics.
At the end of the study, participants who did not learn the BLS and AED algorithm with rescue breaths will be trained in it, so that no participant's training is compromised with respect to current standards.
314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.
This study's planned enrollment of 104 is below the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
First-year nursing students trained in BLS and AED following the traditional algorithm with 30 chest compressions and 2 mouth-to-mouth rescue breaths. Assessed immediately after training (theoretical test and 8-minute simulated CPR) and at 4 months.
Behavioral: BLS and AED Training With Rescue Breaths
First-year nursing students trained in BLS and AED following a simplified model based only on continuous chest compressions, without mouth-to-mouth rescue breaths. Assessed immediately after training (theoretical test and 8-minute simulated CPR) and at 4 months.
Behavioral: BLS and AED Training Without Rescue Breaths
Basic life support (BLS) and automated external defibrillator (AED) training following the traditional European Resuscitation Council algorithm, with cycles of 30 chest compressions and 2 mouth-to-mouth rescue breaths, delivered by official ERC instructors at the UIC simulation centre.
Basic life support (BLS) and automated external defibrillator (AED) training following the same European Resuscitation Council algorithm but with a simplified model based only on continuous chest compressions, without mouth-to-mouth rescue breaths, delivered by official ERC instructors at the UIC simulation centre.
Theoretical-Practical Competence Level in Basic Life Support (BLS) and Automated External Defibrillator (AED) After Training
Composite competence score (range 0-10; higher scores indicate better competence), calculated as the mean of three components, each expressed on a 0-10 scale: (1) final theoretical test (10 multiple-choice questions from the Catalan Resuscitation Council); (2) overall CPR quality recorded by the Resusci Anne QCPR manikin with SkillReporter software (mean of the four 2-minute cycles of the 8-minute simulation); and (3) practical BLS and AED skills rated by the instructor with the CORVAL rubric.
Time frame: Immediately after training (same day as training)
Retention of Theoretical-Practical Competence in BLS and AED
Same composite competence score (range 0-10; higher scores indicate better competence) obtained by repeating the theoretical test and the simulated practical assessment 4 months after training.
Time frame: 4 months after training
Theoretical Knowledge of the BLS and AED Algorithm
Score on the final theoretical test of 10 multiple-choice questions from the Catalan Resuscitation Council (one point per correct answer; range 0-10; higher scores indicate better knowledge).
Time frame: Immediately after training and 4 months after training
Overall CPR Quality Score Recorded by SkillReporter Software
Overall CPR performance score (percentage, range 0-100%; higher values indicate better quality) calculated by the SkillReporter software from the Resusci Anne QCPR manikin, based on chest compression quality and, in the control group, rescue breath quality.
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Chest Compression Quality
Percentage of correctly performed chest compressions (range 0-100%) recorded by the SkillReporter software, based on compression depth, compression rate, full chest recoil, number of compressions and hand position.
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Practical BLS and AED Skills
Score on the CORVAL practical assessment rubric completed by the instructor (items rated 0, 1 or 2; total transformed to a 0-10 scale; higher scores indicate better performance).
Time frame: Immediately after training and 4 months after training
Change in Muscular Fatigue Measured With a Dynamometer From Before to After the 8-Minute Simulated CPR
Decrease in the functional capacity of the specific muscle groups involved in CPR (protocol variable V6), measured with a dynamometer with recording software: sustained 20-second contraction of a hand-held pneumatic bulb. The software records the force curve in real time (not visible to the participant) to identify a decrease in force, neuromuscular irregularities and changes in the stability of the effort. The test is performed before and after the simulation to compare the participant's muscular state. Reported as the change from the value before the simulation (baseline) to the value after the simulation.
Time frame: Immediately before and immediately after the 8-minute simulated CPR on the day of training
Change in Heart Rate From Before to After the 8-Minute Simulated CPR
Heart rate (beats per minute) measured with an arm heart rate monitor and a blood pressure monitor. Reported as the change from the value before the simulation (baseline) to the value after the simulation.
Time frame: Before the simulation, continuously throughout the simulated CPR, and immediately after the simulation on the day of training
Change in Systolic, Diastolic and Mean Arterial Blood Pressure From Before to After the 8-Minute Simulated CPR
Systolic, diastolic and mean arterial blood pressure (mmHg) measured with a validated blood pressure monitor, at rest in a seated position before the simulation and within 60 seconds after finishing CPR, using the same arm, device and cuff size. Reported as the change from the value before the simulation (baseline) to the value after the simulation.
Time frame: Before and within 60 seconds after the 8-minute simulated CPR on the day of training
Change in Perceived Exertion Measured With the Modified Borg Scale From Before to After the 8-Minute Simulated CPR
Perceived physical exertion measured with the modified Borg scale (range 0-10; higher scores indicate greater perceived exertion). Reported as the change from the value before the simulation (baseline) to the value after the simulation.
Time frame: Immediately before and immediately after the 8-minute simulated CPR on the day of training
Participant Satisfaction With the Training Measured With a Likert-Scale Satisfaction Survey
Satisfaction with the content, methodology, organisation and perceived usefulness of the training, measured with a satisfaction survey using a Likert scale (range 0-5; 0 = very dissatisfied, 5 = very satisfied).
Time frame: After the 8-minute simulated CPR on the day of training
Self-Perceived Knowledge of BLS and AED Measured With an Ad Hoc Questionnaire
Self-perceived knowledge of BLS and AED measured with an ad hoc questionnaire (range 0-10; 0 = none, 10 = excellent).
Time frame: Before training, after the 8-minute simulated CPR on the day of training, and 4 months after training
Duration of CPR per Cycle
Duration of CPR in each cycle (minutes), recorded by the SkillReporter software. In this study, this variable is constant: 2 minutes per cycle (protocol variable V2.4).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Correct Hand Position During Chest Compressions
Percentage of chest compressions with correct hand position in the centre of the chest (range 0-100%), recorded by the SkillReporter software (protocol variable V2.7).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Mean Chest Compression Depth
Mean depth of all chest compressions (mm), recorded by the SkillReporter software (protocol variable V2.9).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Chest Compressions With Full Chest Recoil
Percentage of chest compressions with full chest recoil (range 0-100%), recorded by the SkillReporter software (protocol variable V2.10).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Chest Compressions With Adequate Depth
Percentage of chest compressions with adequate depth of 5-6 cm (range 0-100%), recorded by the SkillReporter software (protocol variable V2.11).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Chest Compressions at Correct Rate
Percentage of chest compressions performed at a correct rate of 100-120 compressions per minute (range 0-100%), recorded by the SkillReporter software (protocol variable V2.12).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Chest Compression Rate
Number of chest compressions per minute, recorded by the SkillReporter software (protocol variable V2.13).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Percentage of Participants Competent in BLS and AED (Competence Level of 7 or Higher Out of 10)
Proportion of participants demonstrating an adequate level of competence in performing the BLS and AED algorithm (yes/no), determined from the competence level (protocol variable V4): participants with a competence level of 7 or higher out of 10 are considered competent (protocol variable V5).
Time frame: Immediately after training and 4 months after training
Change in Peripheral Oxygen Saturation From Before to After the 8-Minute Simulated CPR
Peripheral oxygen saturation (SpO2, %) measured with a non-invasive finger pulse oximeter before and after the simulation, outside the CPR period so that the device does not affect CPR quality (protocol variable V7.5). Reported as the change from the value before the simulation (baseline) to the value after the simulation.
Time frame: Before and after the 8-minute simulated CPR on the day of training
Habitual Physical Activity Level Measured With the IPAQ-SF
Physical activity performed in the last 7 days, measured with the International Physical Activity Questionnaire - Short Form (IPAQ-SF): estimated weekly energy expenditure (MET-min/week) and activity level classified as low, moderate or high (protocol variable V10).
Time frame: Before training
Chest Compression Fraction
Percentage of CPR time during which chest compressions were performed (range 0-100%), recorded by the SkillReporter software (protocol variable V2.3). Compared between groups; differences are expected by design because the control group interrupts chest compressions to deliver rescue breaths.
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Hands-Off Time
Time without chest compressions or rescue breaths (seconds), recorded by the SkillReporter software (protocol variable V2.5). Compared between groups; differences are expected by design because the control group interrupts chest compressions to deliver rescue breaths.
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Number of Chest Compressions per Cycle
Number of chest compressions performed in each 2-minute CPR cycle, recorded by the SkillReporter software (protocol variable V2.8). Compared between groups; differences are expected by design because the control group interrupts chest compressions to deliver rescue breaths.
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Rescue Breath Quality
Percentage of correctly performed rescue breaths (range 0-100%), calculated by the SkillReporter software from mean ventilation volume and ventilation rate (protocol variable V2.2). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Complete 30:2 Cycles
Number of complete cycles of 30 chest compressions and 2 rescue breaths, recorded by the SkillReporter software (protocol variable V2.6). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Number of Effective Rescue Breaths
Number of effective rescue breaths in each 2-minute CPR cycle, recorded by the SkillReporter software (protocol variable V2.14). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Mean Ventilation Volume
Mean volume of all effective rescue breaths (ml), recorded by the SkillReporter software (protocol variable V2.15). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Rescue Breaths With Excessive Volume
Percentage of rescue breaths with excessive volume, defined as more than 700 ml (range 0-100%), recorded by the SkillReporter software (protocol variable V2.16). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Rescue Breaths With Adequate Volume
Percentage of rescue breaths with adequate volume, defined as 400-700 ml (range 0-100%), recorded by the SkillReporter software (protocol variable V2.17). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Rescue Breaths With Insufficient Volume
Percentage of rescue breaths with insufficient volume, defined as less than 400 ml (range 0-100%), recorded by the SkillReporter software (protocol variable V2.18). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Ventilation Rate
Number of rescue breaths per minute, recorded by the SkillReporter software (protocol variable V2.19). Assessed in the control group only (descriptive; not compared between groups).
Time frame: At 2, 4, 6 and 8 minutes of the simulated CPR immediately after training, and 4 months after training
Plan to share: No — Individual participant data will not be shared. According to the protocol approved by the Research Ethics Committee, data will be used only for the purpose of this study, will be collected and recorded only at the Universitat Internacional de Catalunya and coded in an SPSS database, and will not be transferred to third parties or outside Spain or the European Union. At the end of the study, all participant data will be destroyed in accordance with Spanish Organic Law 3/2018 and Regulation (EU) 2016/679.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 93 non-industry interventional studies with no phase under Out-of-Hospital Cardiac Arrest, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 4 months is below that.
Counting every sponsor, half of 95 studies reached it within 34 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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