Clinical trial NCT06719401: Comparing Foot and Hand CPR
Official title: Comparing Foot and Hand Cardiopulmonary Resuscitation: a Non- Inferiority, Crossover, Randomised Controlled Simulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest (CA)
Simulation Training
Keywords: foot CPR
simulation study
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean chest compression depth
timeFrame: 1 week after completion of simulation.
Secondary outcomes:
measure: adequate compression depth
timeFrame: 1 week after completion of simulation.
measure: adequate compression rate
timeFrame: 1 week after completion of simulation.
measure: adequate compression depth and rate
timeFrame: 1 week after completion of simulation.
measure: correct chest compression position
timeFrame: 1 week after completion of simulation.
measure: compression with full release
timeFrame: 1 week after completion of simulation.
measure: mean chest compression rate
timeFrame: 1 week after completion of simulation.
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univeristy Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.