Cardiac Arrest (CA)NCT06719401
Comparing Foot and Hand CPR
A study testing Foot Chest Compression and Hand Chest Compression in people with Cardiac Arrest (CA) and Simulation Training, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this simulation study is to evaluate whether chest compression using the foot is comparable to chest compression using the hand during cardiopulmonary resuscitation in trained participants. 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), Simulation Training
- What is being tested?
- Foot Chest Compression and Hand Chest Compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2022to 30 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Certified AHA basic life support provider or undergone equivalent BLS training
Who cannot join
- Unable to perform adequate chest compressions due to:
- physical or cognitive disabilities
- musculoskeletal injuries, such as limb injuries.
- Diagnosed with COVID-19 and quarantined
- Complained of fever or respiratory symptoms suspected to be COVID-19
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univeristy Bundang Hospital
Seongnam-si, Gyeonggi-do, 13611
About this study
Official title: Comparing Foot and Hand Cardiopulmonary Resuscitation: a Non- Inferiority, Crossover, Randomised Controlled Simulation Study
The goal of this simulation study is to evaluate whether chest compression using the foot is comparable to chest compression using the hand during cardiopulmonary resuscitation in trained participants. This study aims to compare the effectiveness of hand chest compression (HCC) with foot chest compression (FCC) and investigate differences in their efficacy based on rescuer characteristics through subgroup analysis. It is designed as a simulation study to assess the efficacy of the FCC method as an alternative to HCC without exposing patients to risk.
Read the detailed description
Study Design and Setting This is a prospective, crossover, non-inferiority, randomised controlled trial. We hypothesise that the FCC method is not inferior to the existing HCC method regarding depth, rate, and chest compression position. The study is approved by the Institutional Review Board (IRB) of Seoul National University Bundang Hospital (B-2205-758-302).
The primary outcomes of this study are the mean chest compression depth (mm) and mean chest compression rate (n/min) for 2 minutes. The secondary outcomes are the proportions of adequate compression depth (%), adequate compression rate (%), adequate compression depth and rate (%), correct chest compression position (%), and compression with full release (%). According to the 2020 AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines, adequate compression depth is defined as a compression of 50-60 mm, and adequate compression rate is defined as a rate of 100-120 compressions per minute. The correct chest compression position is measured using a manikin simulator to ensure that the lower half of the sternum is compressed accurately. If the location of chest compression is incorrect, the chest movement tilts instead of moving horizontally, and this is deemed as an incorrect compression.
Participant Enrollment Participants are recruited through a poster on the information board of a university, following IRB approval. The inclusion criteria for participants are adults aged over 18 years who are certified as AHA Basic Life Support (BLS) providers or have undergone equivalent BLS training. Applicants who meet the following criteria are excluded because they are judged unable to perform adequate chest compressions: (1) physical or cognitive disabilities and (2) musculoskeletal injuries, such as limb injuries. Additionally, as the study is conducted during the COVID-19 pandemic, individuals diagnosed with COVID-19, under quarantine, or experiencing fever or respiratory symptoms suspected to be COVID-19 are excluded.
The purpose of the study is explained to participants who meet the inclusion criteria, including their right to withdraw consent at any time. Participants then complete a written informed consent form to participate in the study.
Simulation Design Participants attend a brief educational session covering the theoretical content of chest compressions, including the importance of compression position, depth, rate, and full release. Education is provided following the 2020 AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines. Additionally, the session includes an explanation of chest compression methods using both hands and feet.
After the educational session, participants are divided into a foot-hand group (F-H group) and a hand-foot group (H-F group) according to whether FCC or HCC is performed first, through random allocation. Participants are then moved to independent rooms (Room A for the F-H group and Room B for the H-F group).
This study uses a crossover design. Participants in the F-H group first perform training and testing using the FCC method and then perform training and testing using the HCC method, while participants in the H-F group follow the opposite order.
- Conditions
- Cardiac Arrest (CA), Simulation Training
- Being tested
- Foot Chest Compression, Hand Chest Compression
- Keywords
- foot CPR, simulation study
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Chest CompressionOther
Foot chest compression is an alternative cardiopulmonary resuscitation (CPR) technique where the rescuer uses one foot to perform compressions on the chest instead of their hands. The heel of the foot is placed on the lower half of the sternum, with the foot parallel to the sternum to ensure effective pressure. The opposite foot provides stability by being positioned beside the patient.
Hand Chest CompressionOther
Hand chest compression is the conventional method of performing chest compressions during CPR. It involves the use of both hands, with one hand placed over the other on the lower half of the sternum. The rescuer positions their body directly over the patient, using the weight of their upper body to deliver compressions of 50-60 mm depth at a rate of 100-120 compressions per minute. Proper technique includes full chest recoil between compressions, maintaining a straight arm posture, and avoiding pressure on the xiphoid process to minimize injury risks. This method adheres to the 2020 AHA guidelines for high-quality CPR.
| Study group | Role | What they receive |
|---|---|---|
| F-H Group | Other | Participants in this group perform training and testing using the foot chest compression (FCC) method first, followed by training and testing using the hand chest compression (HCC) method. Receives: Other: Foot Chest Compression; Other: Hand Chest Compression |
| H-F Group | Other | Participants in this group perform training and testing using the hand chest compression (HCC) method first, followed by training and testing using the foot chest compression (FCC) method. Receives: Other: Foot Chest Compression; Other: Hand Chest Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean chest compression depth
The mean chest compression depth refers to the average depth (mm) achieved during chest compressions for 2 minutes.
Measured: 1 week after completion of simulation.
Secondary outcomes (6)
adequate compression depth
Adequate compression depth is defined as a compression of 50-60 mm, and in this study the percentage of adequate compression depth achieved during a 2 minute period will be calculated.
Measured: 1 week after completion of simulation.
adequate compression rate
Adequate compression rate is defined as a compression rate of 100-120/min, and in this study the percentage of adequate compression rate achieved during a 2 minute period will be calculated.
Measured: 1 week after completion of simulation.
adequate compression depth and rate
The percentage of compressions achieving both adequate compression depth and rate will be obtained.
Measured: 1 week after completion of simulation.
correct chest compression position
The correct chest compression position will be measured using a manikin simulator to ensure that the lower half of the sternum was compressed accurately. The percentage of correct chest compression position will be obtained.
Measured: 1 week after completion of simulation.
compression with full release
The percentage of compression with full release will be obtained using the manikin simulator.
Measured: 1 week after completion of simulation.
mean chest compression rate
The mean chest compression rate represents the average number of compressions delivered per minute (n/min).
Measured: 1 week after completion of simulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Oct 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Keon Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719401
- Sponsor's protocol ID
- B-2205-758-302
- Status last verified
- Dec 2024
- First submitted
- 24 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Trenkamp RH, Perez FJ. Heel compressions quadruple the number of bystanders who can perform chest compressions for 10 minutes. Am J Emerg Med. 2015 Oct;33(10):1449-53. doi: 10.1016/j.ajem.2015.06.070. Epub 2015 Jul 6.
PubMed 26298049Hung TY, Wen CS, Yu SH, Chen YC, Chen HL, Chen WL, Wu CC, Su YC, Lin CL, Hu SC, Lin T. A comparative analysis of aerosol exposure and prevention strategies in bystander, pre-hospital, and inpatient cardiopulmonary resuscitation using simulation manikins. Sci Rep. 2023 Aug 2;13(1):12552. doi: 10.1038/s41598-023-39726-x.
PubMed 37532861Bylow H, Karlsson T, Claesson A, Lepp M, Lindqvist J, Herlitz J. Self-learning training versus instructor-led training for basic life support: A cluster randomised trial. Resuscitation. 2019 Jun;139:122-132. doi: 10.1016/j.resuscitation.2019.03.026. Epub 2019 Mar 26.
PubMed 30926451Wong MF, Ho MP. Leg-heel chest compression as an alternative for medical professionals in times of COVID-19. Am J Emerg Med. 2022 Jul;57:222. doi: 10.1016/j.ajem.2022.02.026. Epub 2022 Feb 19. No abstract available.
PubMed 35219559Peberdy MA, Silver A, Ornato JP. Effect of caregiver gender, age, and feedback prompts on chest compression rate and depth. Resuscitation. 2009 Oct;80(10):1169-74. doi: 10.1016/j.resuscitation.2009.07.003. Epub 2009 Aug 11.
PubMed 19674826Kherbeche H, Exer N, Schuhwerk W, Ummenhofer W, Osterwalder J. Chest compression using the foot or hand method: a prospective, randomized, controlled manikin study with school children. Eur J Emerg Med. 2017 Aug;24(4):262-267. doi: 10.1097/MEJ.0000000000000335.
PubMed 26485692Bae GE, Choi A, Beom JH, Kim MJ, Chung HS, Min IK, Chung SP, Kim JH. Correlation between real-time heart rate and fatigue in chest compression providers during cardiopulmonary resuscitation: A simulation-based interventional study. Medicine (Baltimore). 2021 Apr 23;100(16):e25425. doi: 10.1097/MD.0000000000025425.
PubMed 33879672
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Foot and Hand Cardiopulmonary Resuscitation: a Non- Inferiority, Crossover, Randomised Controlled Simulation Study
- ClinicalTrials.gov ID
- NCT06719401
- Acronym / sponsor ID
- B-2205-758-302
- Conditions
- Cardiac Arrest (CA), Simulation Training
- Keywords
- foot CPR, simulation study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Dec 2024 (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.
The goal of this simulation study is to evaluate whether chest compression using the foot is comparable to chest compression using the hand during cardiopulmonary resuscitation in trained participants. This study aims to compare the effectiveness of hand chest compression (HCC) with foot chest compression (FCC) and investigate differences in their efficacy based on rescuer characteristics through subgroup analysis. It is designed as a simulation study to assess the efficacy of the FCC method as an alternative to HCC without exposing patients to risk.
Detailed description
Study Design and Setting This is a prospective, crossover, non-inferiority, randomised controlled trial. We hypothesise that the FCC method is not inferior to the existing HCC method regarding depth, rate, and chest compression position. The study is approved by the Institutional Review Board (IRB) of Seoul National University Bundang Hospital (B-2205-758-302).
The primary outcomes of this study are the mean chest compression depth (mm) and mean chest compression rate (n/min) for 2 minutes. The secondary outcomes are the proportions of adequate compression depth (%), adequate compression rate (%), adequate compression depth and rate (%), correct chest compression position (%), and compression with full release (%). According to the 2020 AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines, adequate compression depth is defined as a compression of 50-60 mm, and adequate compression rate is defined as a rate of 100-120 compressions per minute. The correct chest compression position is measured using a manikin simulator to ensure that the lower half of the sternum is compressed accurately. If the location of chest compression is incorrect, the chest movement tilts instead of moving horizontally, and this is deemed as an incorrect compression.
Participant Enrollment Participants are recruited through a poster on the information board of a university, following IRB approval. The inclusion criteria for participants are adults aged over 18 years who are certified as AHA Basic Life Support (BLS) providers or have undergone equivalent BLS training. Applicants who meet the following criteria are excluded because they are judged unable to perform adequate chest compressions: (1) physical or cognitive disabilities and (2) musculoskeletal injuries, such as limb injuries. Additionally, as the study is conducted during the COVID-19 pandemic, individuals diagnosed with COVID-19, under quarantine, or experiencing fever or respiratory symptoms suspected to be COVID-19 are excluded.
The purpose of the study is explained to participants who meet the inclusion criteria, including their right to withdraw consent at any time. Participants then complete a written informed consent form to participate in the study.
Simulation Design Participants attend a brief educational session covering the theoretical content of chest compressions, including the importance of compression position, depth, rate, and full release. Education is provided following the 2020 AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines. Additionally, the session includes an explanation of chest compression methods using both hands and feet.
After the educational session, participants are divided into a foot-hand group (F-H group) and a hand-foot group (H-F group) according to whether FCC or HCC is performed first, through random allocation. Participants are then moved to independent rooms (Room A for the F-H group and Room B for the H-F group).
This study uses a crossover design. Participants in the F-H group first perform training and testing using the FCC method and then perform training and testing using the HCC method, while participants in the H-F group follow the opposite order.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-H Group | Other | Other: Foot Chest Compression, Other: Hand Chest CompressionParticipants in this group perform training and testing using the foot chest compression (FCC) method first, followed by training and testing using the hand chest compression (HCC) method. |
| H-F Group | Other | Other: Foot Chest Compression, Other: Hand Chest CompressionParticipants in this group perform training and testing using the hand chest compression (HCC) method first, followed by training and testing using the foot chest compression (FCC) method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Certified AHA basic life support provider or undergone equivalent BLS training
Key exclusion criteria (5 listed)
- Unable to perform adequate chest compressions due to:
- Diagnosed with COVID-19 and quarantined
- Complained of fever or respiratory symptoms suspected to be COVID-19
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 |
|---|---|---|
| Foot Chest CompressionFoot chest compression is an alternative cardiopulmonary resuscitation (CPR) technique where the rescuer uses one foot to perform compressions on the chest instead of their hands. The heel of the foot is placed on the lower half of the sternum, with the foot parallel to the sternum to ensure effective pressure. The opposite foot provides stability by being positioned beside the patient. | Other | F-H Group, H-F Group |
| Hand Chest CompressionHand chest compression is the conventional method of performing chest compressions during CPR. It involves the use of both hands, with one hand placed over the other on the lower half of the sternum. The rescuer positions their body directly over the patient, using the weight of their upper body to deliver compressions of 50-60 mm depth at a rate of 100-120 compressions per minute. Proper technique includes full chest recoil between compressions, maintaining a straight arm posture, and avoiding pressure on the xiphoid process to minimize injury risks. This method adheres to the 2020 AHA guidelines for high-quality CPR. | Other | F-H Group, H-F Group |
Primary outcome
mean chest compression depth
Time frame: 1 week after completion of simulation.
The mean chest compression depth refers to the average depth (mm) achieved during chest compressions for 2 minutes.
6 secondary outcomes
adequate compression depth
Time frame: 1 week after completion of simulation.
adequate compression rate
Time frame: 1 week after completion of simulation.
adequate compression depth and rate
Time frame: 1 week after completion of simulation.
correct chest compression position
Time frame: 1 week after completion of simulation.
compression with full release
Time frame: 1 week after completion of simulation.
mean chest compression rate
Time frame: 1 week after completion of simulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 26298049Trenkamp RH, Perez FJ. Heel compressions quadruple the number of bystanders who can perform chest compressions for 10 minutes. Am J Emerg Med. 2015 Oct;33(10):1449-53. doi: 10.1016/j.ajem.2015.06.070. Epub 2015 Jul 6.
- Background: PubMed 37532861Hung TY, Wen CS, Yu SH, Chen YC, Chen HL, Chen WL, Wu CC, Su YC, Lin CL, Hu SC, Lin T. A comparative analysis of aerosol exposure and prevention strategies in bystander, pre-hospital, and inpatient cardiopulmonary resuscitation using simulation manikins. Sci Rep. 2023 Aug 2;13(1):12552. doi: 10.1038/s41598-023-39726-x.
- Background: PubMed 30926451Bylow H, Karlsson T, Claesson A, Lepp M, Lindqvist J, Herlitz J. Self-learning training versus instructor-led training for basic life support: A cluster randomised trial. Resuscitation. 2019 Jun;139:122-132. doi: 10.1016/j.resuscitation.2019.03.026. Epub 2019 Mar 26.
- Background: PubMed 35219559Wong MF, Ho MP. Leg-heel chest compression as an alternative for medical professionals in times of COVID-19. Am J Emerg Med. 2022 Jul;57:222. doi: 10.1016/j.ajem.2022.02.026. Epub 2022 Feb 19. No abstract available.
- Background: PubMed 19674826Peberdy MA, Silver A, Ornato JP. Effect of caregiver gender, age, and feedback prompts on chest compression rate and depth. Resuscitation. 2009 Oct;80(10):1169-74. doi: 10.1016/j.resuscitation.2009.07.003. Epub 2009 Aug 11.
- Background: PubMed 26485692Kherbeche H, Exer N, Schuhwerk W, Ummenhofer W, Osterwalder J. Chest compression using the foot or hand method: a prospective, randomized, controlled manikin study with school children. Eur J Emerg Med. 2017 Aug;24(4):262-267. doi: 10.1097/MEJ.0000000000000335.
- Background: PubMed 33879672Bae GE, Choi A, Beom JH, Kim MJ, Chung HS, Min IK, Chung SP, Kim JH. Correlation between real-time heart rate and fatigue in chest compression providers during cardiopulmonary resuscitation: A simulation-based interventional study. Medicine (Baltimore). 2021 Apr 23;100(16):e25425. doi: 10.1097/MD.0000000000025425.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Chest Compression and Hand Chest Compression in people with Cardiac Arrest (CA) and Simulation Training, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 5 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 5 Dec 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 South Korea. 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: 1 week after completion of simulation.). 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 NCT06719401, which also lists 7 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 5 Dec 2024.