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Cardiac Arrest (CA)NCT07074080

Hand vs. Foot Chest Compressions in Simulation

A study testing Performing chest compressions on a mannequin using the foot and Performance of standard chest compressions with the upper limbs. in people with Cardiac Arrest (CA), run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiopulmonary resuscitation (CPR) is essential in the management of cardiorespiratory arrest (CA) to improve survival rates. High-quality chest compressions are the primary intervention to maintain circulation and oxygenation of vital organs during cardiac arrest, making them a key determinant in CPR effectiveness. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiac Arrest (CA)
What is being tested?
Performing chest compressions on a mannequin using the foot and Performance of standard chest compressions with the upper limbs.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteSpain
Study dates
6 Jun 2025to 17 Jun 2025
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Signed informed consent
  • First-year postgraduate trainees in health-related fields such as medicine or nursing
  • Enrolled in a Basic Life Support and Automated External Defibrillation (BLS+AED) course from the Consell Català de Resuscitació - European Resuscitation Council

Who cannot join

  • Physical limitations preventing chest compressions with hands or feet
  • Contraindications for physical exercise (e.g., arthritis, heart disease, advanced lung disease, severe physical disability, morbid obesity, chronic fatigue, pregnancy).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Facultad de Medicina de La Universidad de Barcelona

    Barcelona, BARCELONA, 08036

Other trials in Spain

About this study

Official title: Comparative Study of Hand vs. Foot Chest Compressions in a Simulated Environment: Assessment of Compression Effectiveness and Rescuer Fatigue

Cardiopulmonary resuscitation (CPR) is essential in the management of cardiorespiratory arrest (CA) to improve survival rates. High-quality chest compressions are the primary intervention to maintain circulation and oxygenation of vital organs during cardiac arrest, making them a key determinant in CPR effectiveness.

Guidelines emphasize that the quality of chest compressions is a critical factor in the effectiveness of basic life support (BLS). To ensure efficacy, a compression rate of 100 to 120 per minute is recommended, with a depth of at least 5 cm but not exceeding 6 cm, proper arm and hand alignment, full chest recoil after each compression, minimal interruptions during CPR, and rescuer rotation every 2 minutes to prevent performance decline due to fatigue.

Read more

As we can see, these guidelines refer to performing compressions using the upper limbs. However, it is essential to acknowledge that some individuals have physical limitations that may impair their ability to apply effective force with their upper limbs (e.g., amputations, fractures, neuromuscular dysfunctions). This presents important challenges regarding accessibility and inclusive CPR training. In addition, the use of the lower extremities has been proposed as an alternative to potentially reduce rescuer fatigue, although evidence regarding its effectiveness and impact on physiological fatigue is still limited.

There are studies comparing chest compressions performed with the hands (Hands Method, HMM) and with the feet (Foot Method, FMM); however, these studies have certain limitations and a limited number of participants. Although the quality of CPR was lower when using the feet technique, the results were positive.

However, to date, no specific guidelines have been established on how to perform CPR using the feet (Foot CPR), and it remains unclear whether the position of the feet on the chest or whether compressions are performed with or without shoes are variables that influence compression quality.

Furthermore, during CPR, it is recommended to rotate rescuers every 2 minutes when two or more rescuers are available due to fatigue associated with the procedure. Current evidence suggests that CPR is most effectively performed in the kneeling position, rather than standing or using a stool, due to the lower levels of fatigue in this position.

Traditionally, exercise-induced fatigue is assessed using subjective perception of exertion (RPE), performance monitoring (e.g., power or speed), or biochemical markers (e.g., blood lactate). More recently, heart rate variability (HRV) has been proposed as a valuable tool for assessing the autonomic nervous system response to exercise stress and quantifying physiological fatigue.

After exercise, especially if it is intense or prolonged, the body experiences significant physiological stress. This stress affects multiple systems, including the cardiovascular and autonomic nervous systems. Post-exercise fatigue is a complex sensation involving muscular, metabolic, and neuronal factors. Therefore, HRV becomes a valuable biomarker.

Numerous studies have shown a correlation between decreased HRV and the subjective perception of fatigue after exercise. People with lower heart rate variability (HRV) after exercise tend to report higher levels of fatigue. HRV analysis provides an objective and physiological measure of the stress the body experiences after short-duration, high-intensity exercise, such as that performed during resuscitation.

Therefore, measuring HRV after 2 minutes of chest compressions can indicate the degree of exercise-induced physiological fatigue, which could vary depending on the technique used (Hands-on CPR [H-CPR] vs. Feet-on CPR [F-CPR]).

Efforts to improve outcomes should focus on optimizing the chain of survival through training in Basic Life Support and Automated External Defibrillation (BLS + AED). Offering these courses to the general population presents significant challenges in terms of accessibility and implementation of comprehensive and inclusive training.

The objective of our randomized simulation study using mannequins, with a population of Basic Life Support students, was to compare the quality of chest compressions and the fatigue produced by this technique, in compressions performed with the hands and with the foot.

Read the detailed description

This is a single-center, randomized, crossover, controlled study conducted in the Skills Laboratory of the Faculty of Medicine and Health Sciences, Campus Clínic. Each participant will act as their own control, performing chest compressions with both hands and their foot. The order of compression method (hand or foot) will be randomly assigned, and participants will subsequently perform the alternative method they did not initially complete.

Participants will be enrolled in a Basic Life Support and Automated External Defibrillation (BLS+AED) course from the Catalan Resuscitation Council - European Resuscitation Council.

Data collection will be consecutive and open-label.

Variable-size block randomization, generated using statistical software, will be used to ensure balanced assignment of participants to the study groups while maintaining unpredictability.

To implement this randomization, the R programming language will be used, widely used in scientific research and statistical analysis due to its robustness and reliability. R offers specialized tools for this type of randomization, ensuring a rigorous, transparent, and reproducible process.

We will use the R package blockrand, specifically designed for efficient and controlled block randomization.

Primary objectives:

To compare the depth of uninterrupted chest compressions (without ventilation) delivered over a 2-minute period during a simulated cardiac arrest on the floor, using either the hands (HM) or feet (FM).

To assess CPR-associated fatigue in the two groups using:

Subjective measures: Rating of perceived exertion (Borg score). Direct objective measures: Use of a wearable health monitoring device (abdominal strap-based) to measure rescuer heart rate variability (HRV), a parameter correlated with fatigue during CPR.

Indirect objective measures: heart rate and oxygen saturation.

Data will be collected using the SkillReporter® app (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin, a certified medical-grade abdominal strap (Movesense®), and a pulse oximeter.

Being tested
Performing chest compressions on a mannequin using the foot, Performance of standard chest compressions with the upper limbs.
Keywords
CA (Cardiac Arrest), CPR (Cardiopulmonary Resuscitation), CPR-FOOT (Foot-based Cardiopulmonary Resuscitation), (HRV) Heart Rate Variability
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Performing chest compressions on a mannequin using the footOther

    Performing chest compressions on a mannequin using the foot

  • Performance of standard chest compressions with the upper limbs.Other

    Performance of standard chest compressions with the upper limbs.

Study groups in NCT07074080
Study groupRoleWhat they receive
HM - Hand MethodActive comparatorNot described
Receives: Other: Performance of standard chest compressions with the upper limbs.
FM - Foot MethodExperimentalNot described
Receives: Other: Performing chest compressions on a mannequin using the foot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MEAN CHEST COMPRESSION DEPTH

    Data will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin.

    Primary Variable:

    Mean chest compression depth: To compare the mean depth of uninterrupted chest compressions (without ventilations) performed over a 2-minute period during a simulated cardiac arrest on the floor using the hands (HM) or the feet in both positions (FM-S and FM-T).

    Measured: One day

  2. DFA α1 (DETRENDED FLUCTUATION ANALYSIS - α1)

    DFA α1 - Short-term scaling exponent from Detrended Fluctuation Analysis (DFA) is a nonlinear HRV metric derived from detrended fluctuation analysis, representing short-term fractal scaling behavior of RR intervals. Assesses fractal-like correlation properties of heart rate time series over short time scales. It provides insights into the complexity and self-regulation of autonomic control. Values closer to 1.0 indicate healthy, adaptable systems, while deviations may suggest altered autonomic regulation.

    Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

Secondary outcomes (17)
  1. OVERALL COMPRESSION SCORE

    Overall compression score (%): A variable created by Laerdal Medical® reflecting how closely CPR performance aligns with ERC Guidelines. Deviations reduce the score from 100%. The score incorporates depth, rate, incomplete release, number of compressions per cycle, and hand/foot positioning.

    Measured: One day

  2. TOTAL NUMBER OF COMPRESSIONS

    Total number of compressions will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  3. COMPRESSION / DESCOMPRESSION RATIO

    This variable refers to the ratio between the duration of the downward chest compression and the upward chest recoil (decompression). Compression/decompression ratio will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  4. CORRECT COMPRESSION DEPTH

    Correct compression depth (%): percentage of chest compressions with a depth between 5 and 6 cm. Data will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  5. COMPRESSION RELEASE

    Compression release (%) refers to the percentage of chest compressions in which full chest recoil was achieved. Compression release (%) will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  6. MEAN COMPRESSION RATE

    Mean compression rate refers to the average number of chest compressions delivered per minute (cpm). Data will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  7. CORRECT HANDS/FEET POSITION

    Correct hand/feet position (%): Correct Hand/Feet Position (%) refers to the percentage of chest compressions performed with the hands or feet placed correctly Data will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  8. TOTAL NUMBER OF BREAKS

    Total number of breaks: The total count of pauses or interruptions during chest compressions Data will be collected using the SkillReporter® application (Laerdal Medical®) during 2 minutes of continuous chest compressions on a Resusci Anne QCPR manikin

    Measured: One day

  9. BORG SCALE

    The Borg Scale measures perceived exertion or subjective intensity of effort during chest compressions. The Borg scale will be used before and after compressions to assess perceived fatigue in all groups.

    Measured: One day for each participant (3 weeks in total).

  10. STANDARD DEVIATION OF NN INTERVALS (SDNN)

    SDNN (Standard Deviation of NN intervals): Reflects overall heart rate variability (HRV) by measuring the standard deviation of all normal-to-normal (NN) intervals. It indicates general autonomic activity and long-term components of variability. Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  11. ROOT MEAN SQUARE OF SUCCESSIVE DIFFERENCES (RMSSD)

    RMSSD (Root Mean Square of Successive Differences): Represents the short-term heart rate variability (HRV by calculating the square root of the mean squared differences between adjacent NN intervals. It is primarily influenced by parasympathetic (vagal) activity. Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  12. LOW FREQUENCY (LF)

    Low Frequency (LF) refers to the power of heart rate variability (HRV) within the frequency range of 0.04 to 0.15 Hz in spectral (frequency-domain) analysis.

    This means it reflects oscillations in heart rate that occur every 7 to 25 seconds.Represents a combination of sympathetic and parasympathetic modulation, commonly associated with baroreflex activity.

    Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  13. HIGH FREQUENCY (HF)

    High Frequency (HF) refers to the power of heart rate variability within the frequency range of 0.15 to 0.40 Hz in spectral (frequency-domain) analysis.

    This corresponds to oscillations in heart rate occurring approximately every 2.5 to 7 seconds, which are strongly linked to respiratory activity. HF (High Frequency, 0.15-0.40 Hz): Reflects parasympathetic activity and is related to respiratory sinus arrhythmia.

    Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  14. LOW FREQUECY (LF) /HIGH FREQUENCY (HF) RATIO

    The LF/HF ratio is the ratio of Low Frequency (LF) power to High Frequency (HF) power in the spectral analysis of heart rate variability (HRV). LF/HF Ratio Indicates the balance between sympathetic and parasympathetic nervous system activity. An increased ratio may reflect sympathetic dominance.

    Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®).

    HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  15. JT/RR ratio

    The JT/RR ratio is the ratio between the JT interval and the RR interval on an ECG.

    Change in heart rate variability (HRV), measured before and after performing the two minutes of CPR using a certified medical-grade abdominal band device (Movesense®). HRV is a non-invasive indicator of autonomic nervous system (ANS) activity and is known to be affected by physical fatigue and physiological stress.

    Measured: One day

  16. SpO₂

    SpO₂: Oxygen saturation measured by a portable digital pulse oximeter before and after 2 min of chest compressions

    Measured: one day

  17. PULSE RATE

    Pulse rate: Number of heartbeats per minute (bpm), measured via pulse waveform by a portable digital pulse oximeter before and after 2 minutes of chest compressions.

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start6 Jun 2025
  3. Primary completion6 Jun 2025
  4. Study completion17 Jun 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
This is a single-center, randomized, crossover, and controlled study conducted at the Skills Laboratory of the Faculty of Medicine and Health Sciences, Campus Clínic. Each participant will serve as their own control, performing chest compressions using both the hands and the foot. The order of the compression method (manual or foot) will be randomly assigned, with participants subsequently performing the alternative method they did not initially complete.
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074080
Sponsor's protocol ID
FOOT-CPR 2025
Status last verified
Jun 2025
First submitted
5 Jun 2025
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: At the time of inclusion in the study and after signing the informed consent, personal data will be coded. The data (with coded information) will be collected in an Excel® database, which will be accessible to the collaborating researchers. Access to identifiable data will be restricted to the principal investigator, who will keep it for a maximum of 5 years.

Questions about this trial

What is this clinical trial studying?

A study testing Performing chest compressions on a mannequin using the foot and Performance of standard chest compressions with the upper limbs. in people with Cardiac Arrest (CA), run by Hospital Clinic of Barcelona 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MEAN CHEST COMPRESSION DEPTH (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jul 2025.

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