Comparing Foot and Hand CPR

December 3, 2024 updated by: Dong Keon Lee, Seoul National University Hospital

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.

Study Overview

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13611
        • Seoul National Univeristy Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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:

    1. physical or cognitive disabilities
    2. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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