Comparison of Standard CPR and CPR Feedback Devices in Terms of the Effectiveness of Chest Compressions During Cardiopulmonary Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Chest compression rate
研究概览
简要总结
The objective of this educational clinical trial is to compare auditory (metronome) and audiovisual (TrueCPR) feedback systems with both standard CPR and with each other in a simulated environment, focusing on their effects on chest compression quality.
The main research questions are:
- Does the use of a metronome improve CPR performance metrics compared to standard CPR?
- Does the use of TrueCPR improve CPR performance metrics compared to standard CPR?
- Is TrueCPR more effective than the metronome in improving CPR performance metrics?
Researchers will evaluate the impact of auditory (metronome) and audiovisual (TrueCPR) feedback systems on chest compression quality by comparing them to standard CPR and to each other within a simulated clinical educational environment.
Participants:
A total of 179 participants, consisting of medical students (n = 112) and paramedic students (n = 67), will be involved in the study.
All participants will attend a 30-minute orientation session. Participants who meet the inclusion criteria and agree to participate (medicine, n = 21; paramedic, n = 62) will sign an informed consent form prior to the study.
They will then complete a preliminary assessment, including a 5-question knowledge test on high-quality CPR metrics.
Perform 2 minutes of chest-compressions-only CPR (standard CPR) on a manikin without any feedback.
All participants will be pooled and randomized. They will receive a 10-minute general briefing session after randomization.
Study Groups:
Group1: Standard-to-Metronome Group (n = 43) will:
Perform 2 minutes of chest-compressions-only CPR (standard CPR) on a manikin without any feedback.
Not receive device-specific training or use a multisensory feedback device. Take a 5-minute rest period. Perform 2 minutes of CPR using metronome feedback.
Group 2: Standard-to-TrueCPR (n = 40) will:
Perform 2 minutes of chest-compressions-only CPR (standard CPR) on a manikin without any feedback.
Receive a 30-minute TrueCPR-specific training session and use a multisensory feedback device.
Take a 5-minute rest period. Perform 2 minutes of CPR using TrueCPR feedback.
详细描述
A. Study Preparation Study Setting This study was conducted in the Professional Skills Laboratories of Başkent University Faculty of Medicine. Basic Life Support (BLS) simulations were organized as standardized, single-station sessions and performed on an advanced ACLS manikin situated in a spacious hands-on training room. While one participant performed chest compressions, others waited in a nearby area until it was their turn.
Research Personnel Two faculty members designed the simulation environment and BLS scenarios, supervised orientation training for both investigators and participants, and coordinated study sessions. Additionally, five medical student researchers assisted in setting up the simulation environment, managing participant flow, delivering orientation sessions, and obtaining informed consent.
Orientation Session A 30-minute orientation session was held on two separate days for the study population (medicine, n = 112; paramedic, n = 67), during which the study purpose, pre- and post-randomization procedures, study setting, and participant expectations were explained.
Preliminary Assessment Before the randomization phase, a preliminary assessment was conducted to evaluate the similarities in high-quality CPR knowledge and performance between medical and paramedic students.
- Participants who attended the orientation were invited to participate in the study (n = 83). Demographic data were collected, and informed consent was obtained from volunteers meeting the inclusion criteria (medicine, n = 21; paramedic, n = 62).
- A five-question knowledge test covering key high-quality CPR metrics was administered. The test scores were recorded for all eligible participants.
- Each participant then performed 2 minutes of chest-compressions-only CPR on an advanced ACLS manikin without feedback. Compression rate, depth, and residual leaning percent were recorded for each participant.
- Knowledge test and performance data were analyzed separately for medical and paramedic students.
- Analyses showed no significant differences in theoretical knowledge or practical performance between the two groups.
- Due to this equivalence, participants were pooled and randomized irrespective of their educational background.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding was maintained during data analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a first- or second-year student in the medical school or paramedic program
- •Having completed a standardized Basic Life Support (BLS) course as part of the curriculum
- •Having no prior experience with CPR feedback devices
- •Voluntarily agreeing to participate and signing the informed consent form
- •Being able to complete all required chest compression steps during the study procedure
排除标准
- •Being a student other than first- or second-year in the medical school or paramedic program
- •Not having completed a standardized Basic Life Support (BLS) course as part of the academic curriculum
- •Having prior experience with CPR feedback devices
- •Refusing to participate or failing to sign the informed consent form
- •Being unable to perform all required chest compression steps during the study procedure
研究组 & 干预措施
Group 1: Standard-to-Metronome Group
The Standard-to-Metronome group (Group 1, n = 43) did not have device-specific training and multisensory feedback. In our study, the metronome function was used as a coaching device, optionally integrated with an advanced manikin. This group performed chest compressions without feedback on an advanced manikin, followed by compressions assisted by a metronome providing auditory feedback only, without receiving any device-specific training or multisensory input.
干预措施: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin (Device)
Group 1: Standard-to-Metronome Group
The Standard-to-Metronome group (Group 1, n = 43) did not have device-specific training and multisensory feedback. In our study, the metronome function was used as a coaching device, optionally integrated with an advanced manikin. This group performed chest compressions without feedback on an advanced manikin, followed by compressions assisted by a metronome providing auditory feedback only, without receiving any device-specific training or multisensory input.
干预措施: Metronome (Device)
Group 2: Standard-to-TrueCPR Group
The Standard-to-TrueCPR Group (Group 2, n = 39) had TrueCPR-specific training and multisensory feedback. TrueCPR is a CPR feedback device equipped with auditory, visual, and cognitive feedback features. Feedback devices monitor each compression and offer corrective information based on real-time performance. This group performed chest-compressions-only CPR without feedback on an advanced manikin, then received training on TrueCPR, and then performed compressions assisted by TrueCPR.
干预措施: TrueCPR Multisensory Feedback Device (Device)
Group 2: Standard-to-TrueCPR Group
The Standard-to-TrueCPR Group (Group 2, n = 39) had TrueCPR-specific training and multisensory feedback. TrueCPR is a CPR feedback device equipped with auditory, visual, and cognitive feedback features. Feedback devices monitor each compression and offer corrective information based on real-time performance. This group performed chest-compressions-only CPR without feedback on an advanced manikin, then received training on TrueCPR, and then performed compressions assisted by TrueCPR.
干预措施: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin (Device)
结局指标
主要结局
Chest compression rate
时间窗: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
One of the primary outcomes of the study was the chest compression (CC) rate, measured in compressions per minute (cpm). According to the 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation, a key component of high-quality CPR is maintaining an optimal CC rate of 100 to 120 cpm in adult patients. This rate ensures sufficient blood flow during cardiac arrest while minimizing the risk of inadequate ventricular filling. In our study, CC rate outcomes were objectively measured and recorded using the Ambu SmartMan ALS Pro+ (AW301) manikin.
Chest compression depth
时间窗: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
One of the primary outcomes of the study was the chest compression (CC) depth, measured in millimeters (mm). According to the 2020 American Heart Association (AHA) Guidelines, high-quality CPR requires a CC depth of 5 to 6 centimeters (50-60 millimeters) in adults to ensure adequate blood flow during resuscitation. In this study, CC depth outcomes were measured and recorded using the Ambu SmartMan ALS Pro+ (AW301) manikin.
Chest compression rate
时间窗: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
One of the primary outcomes of the study was the chest compression (CC) rate, measured in compressions per minute (cpm). According to the 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation, a key component of high-quality CPR is maintaining an optimal CC rate of 100 to 120 cpm in adult patients. This rate ensures sufficient blood flow during cardiac arrest while minimizing the risk of inadequate ventricular filling. In our study, CC rate outcomes were objectively measured and recorded using the Ambu SmartMan ALS Pro+ (AW301) manikin.
Chest compression depth
时间窗: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
One of the primary outcomes of the study was the chest compression (CC) depth, measured in millimeters (mm). According to the 2020 American Heart Association (AHA) Guidelines, high-quality CPR requires a CC depth of 5 to 6 centimeters (50-60 millimeters) in adults to ensure adequate blood flow during resuscitation. In this study, CC depth outcomes were measured and recorded using the Ambu SmartMan ALS Pro+ (AW301) manikin.
Leaning percent
时间窗: From randomization until the end of the chest compression sessions, within a 60-minute period.
One of the primary outcomes of the study was the Leaning Percent (LP), measured as a percentage (%). According to the 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation, complete release after each compression is essential to ensure optimal cardiac filling and perfusion. Leaning percent reflects how often chest compressions are performed without allowing full chest recoil. Incomplete release can compromise the effectiveness of CPR. In this study, the Ambu SmartMan ALS Pro+ (AW301) manikin automatically recorded the number of compressions with incomplete release during each 120-second chest-compression-only session. The LP was calculated using the formula: Leaning % = (Compressions with incomplete release / Total compressions) × 100.
次要结局
未报告次要终点
研究者
Betül Akbuğa Özel
Assistant Professor, MD, FTBEM, MSc, PhD
Ankara City Hospital Bilkent