NCT07074080

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

June 5, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

CA (Cardiac Arrest)CPR (Cardiopulmonary Resuscitation)CPR-FOOT (Foot-based Cardiopulmonary Resuscitation)(HRV) Heart Rate Variability

Outcome Measures

Primary Outcomes (2)

  • 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).

    One day

  • 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.

    One day

Secondary Outcomes (17)

  • OVERALL COMPRESSION SCORE

    One day

  • TOTAL NUMBER OF COMPRESSIONS

    One day

  • COMPRESSION / DESCOMPRESSION RATIO

    One day

  • CORRECT COMPRESSION DEPTH

    One day

  • COMPRESSION RELEASE

    One day

  • +12 more secondary outcomes

Study Arms (2)

HM - Hand Method

ACTIVE COMPARATOR
Other: Performance of standard chest compressions with the upper limbs.

FM - Foot Method

EXPERIMENTAL
Other: Performing chest compressions on a mannequin using the foot

Interventions

Performing chest compressions on a mannequin using the foot

FM - Foot Method

Performance of standard chest compressions with the upper limbs.

HM - Hand Method

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina de La Universidad de Barcelona

Barcelona, BARCELONA, 08036, Spain

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

July 20, 2025

Study Start

June 6, 2025

Primary Completion

June 6, 2025

Study Completion

June 17, 2025

Last Updated

July 20, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Locations