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临床试验/NCT06719401
NCT06719401已完成不适用

Comparing Foot and Hand Cardiopulmonary Resuscitation: a Non- Inferiority, Crossover, Randomised Controlled Simulation Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
mean chest compression depth

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age > 18 years
  • •Certified AHA basic life support provider or undergone equivalent BLS training

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Foot Chest Compression (Other)

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.

干预措施: Hand Chest Compression (Other)

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.

干预措施: Foot Chest Compression (Other)

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.

干预措施: Hand Chest Compression (Other)

结局指标

主要结局

mean chest compression depth

时间窗: 1 week after completion of simulation.

The mean chest compression depth refers to the average depth (mm) achieved during chest compressions for 2 minutes.

次要结局

  • adequate compression depth(1 week after completion of simulation.)
  • adequate compression rate(1 week after completion of simulation.)
  • adequate compression depth and rate(1 week after completion of simulation.)
  • correct chest compression position(1 week after completion of simulation.)
  • compression with full release(1 week after completion of simulation.)
  • mean chest compression rate(1 week after completion of simulation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Keon Lee

Associate professor

Seoul National University Hospital

研究点 (1)

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