Comparing Foot and Hand CPR

Not Applicable

Completed

• Conditions: Cardiac Arrest (CA); Simulation Training

• Registration Number: NCT06719401
• Lead Sponsor: Seoul National University Hospital

Brief 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. 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 Timeline

• Study Start: 2022-10-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Study First Submitted: 2024-11-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
mean chest compression depth	1 week after completion of simulation.	The mean chest compression depth refers to the average depth (mm) achieved during chest compressions for 2 minutes.

Secondary Outcome Measures

Name	Time	Method
adequate compression depth	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.
adequate compression rate	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.
adequate compression depth and rate	1 week after completion of simulation.	The percentage of compressions achieving both adequate compression depth and rate will be obtained.
correct chest compression position	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.
compression with full release	1 week after completion of simulation.	The percentage of compression with full release will be obtained using the manikin simulator.
mean chest compression rate	1 week after completion of simulation.	The mean chest compression rate represents the average number of compressions delivered per minute (n/min).

Trial Locations

Locations (1)

Seoul National Univeristy Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of