- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06719401
Comparing Foot and Hand CPR
Comparing Foot and Hand Cardiopulmonary Resuscitation: a Non- Inferiority, Crossover, Randomised Controlled Simulation Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 13611
- Seoul National Univeristy Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years
- Certified AHA basic life support provider or undergone equivalent BLS training
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: F-H Group
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.
|
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 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: H-F Group
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.
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week after completion of simulation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adequate compression depth
Time Frame: 1 week after completion of simulation.
|
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.
|
1 week after completion of simulation.
|
|
adequate compression rate
Time Frame: 1 week after completion of simulation.
|
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.
|
1 week after completion of simulation.
|
|
adequate compression depth and rate
Time Frame: 1 week after completion of simulation.
|
The percentage of compressions achieving both adequate compression depth and rate will be obtained.
|
1 week after completion of simulation.
|
|
correct chest compression position
Time Frame: 1 week after completion of simulation.
|
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.
|
1 week after completion of simulation.
|
|
compression with full release
Time Frame: 1 week after completion of simulation.
|
The percentage of compression with full release will be obtained using the manikin simulator.
|
1 week after completion of simulation.
|
|
mean chest compression rate
Time Frame: 1 week after completion of simulation.
|
The mean chest compression rate represents the average number of compressions delivered per minute (n/min).
|
1 week after completion of simulation.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Bylow 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.
- 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.
- Hung 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.
- Wong 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.
- Peberdy 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.
- Kherbeche 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.
- Bae 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2205-758-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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