Effectiveness of Chest Compressions With Standard vs Feedback-Assisted CPR
NCT ID: NCT07029724
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2016-04-22
2016-05-02
Brief Summary
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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.
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Detailed Description
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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.
Randomization
Two sets of labels were prepared: one labeled "standard to metronome" and "standard to TrueCPR," and the other labeled "Group 1" and "Group 2." These were matched by blind draw to assign the intervention types to each group:
Group 1: Metronome group, "Standard to Metronome" (no device-specific training or multisensory feedback) Group 2: TrueCPR group, "Standard to TrueCPR" (device-specific training and audiovisual feedback)
Of 179 eligible participants, 83 met the inclusion criteria, demonstrated equivalent knowledge and performance, gave informed consent, and were randomized. A block randomization method (1:1 ratio) was implemented using a web-based tool (Urbaniak GC, http://www.randomizer.org/) to ensure balanced allocation. Participants were assigned to either Group 1 (n = 43) or Group 2 (n = 40). The slight imbalance reflected differences in enrollment timing and participant availability and was acceptable within block design limits.
To maintain allocation concealment, the randomization sequence was generated and managed by an independent researcher not involved in recruitment or data collection. The allocation list was stored securely and remained inaccessible to investigators until the assignment.
Because standard CPR, metronome-assisted CPR, and TrueCPR-assisted CPR are clearly distinguishable in cognitive, visual, and auditory dimensions, the study was conducted as open-label for researchers, participants, and the data analyst.
B. Study Interventions Group assignments were performed by an independent researcher prior to the start of the trial to ensure unbiased allocation.
Group 1 (n = 43): Performed chest-compressions-only CPR (standard CPR) followed by metronome-assisted CPR, without receiving any specific training or multisensory feedback.
Group 2 (n = 40): Performed device-specific training (TrueCPR) and performed chest-compressions-only CPR (standard CPR) followed by TrueCPR-assisted CPR with auditory and visual feedback. In this group, one participant did not complete the CPR session with TrueCPR.The number of participants included in the analyses was 39 (n = 39).
Intervention Steps
1. At the beginning of the trial, both groups received a standardized 10-minute briefing, including an overview of the study protocol, orientation to the simulation lab, and introduction to the research team.
2. In a single-station setup:
Group 1 participants first performed 2 minutes of standard CPR without ventilation or feedback. After a 5-minute rest, they performed another 2 minutes of CPR assisted by a metronome. The metronome feature was embedded in the advanced ACLS manikin and provided auditory feedback only. No additional training was given.
3. On a different day, using the same station:
Group 2 participants first performed 2 minutes of standard CPR without feedback. Then, they received a 30-minute device-specific TrueCPR training, which included:
A 10-minute instructional video, A 10-minute didactic session, A 5-minute demonstration and Q\&A session, A 2-minute individual hands-on practice, A 5-minute rest period. Finally, they performed 2 minutes of CPR using the TrueCPR device, which provided real-time audiovisual feedback.
4. Chest compression rate (cpm), depth (mm), and leaning percent (%) were measured and recorded during standard CPR, metronome-guided CPR, and TrueCPR-assisted CPR using the Ambu SmartMan ALS Pro+ (AW301) manikin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Ambu Smartman ALS Pro+ (AW301) Simulation Manikin
The Ambu SmartMan ALS Pro+ (AW301) is an advanced simulation manikin designed to support training in both Basic and Advanced Life Support (BLS and ACLS). It features multiple operational modes, including feedback, skills, code, and application modules, with or without manikin dependency. The manikin provides real-time auditory feedback through an integrated metronome and allows online monitoring by instructors. It records performance metrics such as compression depth and rate, compression-to-decompression ratio, hand position accuracy, and number of compressions with leaning.
Metronome
The Ambu SmartMan ALS Pro+ (AW301), which is an advanced simulation manikin, offers real-time auditory feedback via an integrated metronome function. Devices that provide only a fixed auditory tempo-such as a metronome-are generally classified as coaching devices, because they do not measure or analyze the user's actions during CPR.
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.
TrueCPR Multisensory Feedback Device
TrueCPR (Physio-Control, Inc., Redmond, WA, USA) is a real-time CPR feedback device that provides both visual and auditory cues to support the delivery of high-quality chest compressions. The system consists of two pads (chest and back) that measure compression depth using electromagnetic signal transmission. The device offers auditory rate guidance via a metronome and visual feedback through a color display indicating the adequacy of compression depth and recoil. Performance data-including compression depth, rate, ratio, and the percentage of compressions that are too shallow or too deep-are recorded and analyzed using dedicated software. TrueCPR delivers multisensory feedback (auditory and visual) for both professional rescuers and trainees.
Ambu Smartman ALS Pro+ (AW301) Simulation Manikin
The Ambu SmartMan ALS Pro+ (AW301) is an advanced simulation manikin designed to support training in both Basic and Advanced Life Support (BLS and ACLS). It features multiple operational modes, including feedback, skills, code, and application modules, with or without manikin dependency. The manikin provides real-time auditory feedback through an integrated metronome and allows online monitoring by instructors. It records performance metrics such as compression depth and rate, compression-to-decompression ratio, hand position accuracy, and number of compressions with leaning.
Interventions
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TrueCPR Multisensory Feedback Device
TrueCPR (Physio-Control, Inc., Redmond, WA, USA) is a real-time CPR feedback device that provides both visual and auditory cues to support the delivery of high-quality chest compressions. The system consists of two pads (chest and back) that measure compression depth using electromagnetic signal transmission. The device offers auditory rate guidance via a metronome and visual feedback through a color display indicating the adequacy of compression depth and recoil. Performance data-including compression depth, rate, ratio, and the percentage of compressions that are too shallow or too deep-are recorded and analyzed using dedicated software. TrueCPR delivers multisensory feedback (auditory and visual) for both professional rescuers and trainees.
Ambu Smartman ALS Pro+ (AW301) Simulation Manikin
The Ambu SmartMan ALS Pro+ (AW301) is an advanced simulation manikin designed to support training in both Basic and Advanced Life Support (BLS and ACLS). It features multiple operational modes, including feedback, skills, code, and application modules, with or without manikin dependency. The manikin provides real-time auditory feedback through an integrated metronome and allows online monitoring by instructors. It records performance metrics such as compression depth and rate, compression-to-decompression ratio, hand position accuracy, and number of compressions with leaning.
Metronome
The Ambu SmartMan ALS Pro+ (AW301), which is an advanced simulation manikin, offers real-time auditory feedback via an integrated metronome function. Devices that provide only a fixed auditory tempo-such as a metronome-are generally classified as coaching devices, because they do not measure or analyze the user's actions during CPR.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Baskent University
OTHER
Betül Akbuğa Özel
OTHER
Responsible Party
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Betül Akbuğa Özel
Assistant Professor, MD, FTBEM, MSc, PhD
Principal Investigators
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Betül Akbuğa Özel, Asst. Prof.
Role: PRINCIPAL_INVESTIGATOR
Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine
Locations
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Ankara Bilkent City Hospital, Ankara Yıldırım Beyazıt University, Faculty of Medicine, of Emergency Medicine
Çankaya, Ankara, Turkey (Türkiye)
Başkent University
Etimesgut, Ankara, Turkey (Türkiye)
Countries
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References
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Smereka J, Szarpak L, Czekajlo M, Abelson A, Zwolinski P, Plusa T, Dunder D, Dabrowski M, Wiesniewska Z, Robak O, Frass M, Sivrikaya G U, Ruetzler K. The TrueCPR device in the process of teaching cardiopulmonary resuscitation: A randomized simulation trial. Medicine (Baltimore). 2019 Jul;98(27):e15995. doi: 10.1097/MD.0000000000015995.
Lin Y, Lockey A, Donoghue A, Greif R, Cortegiani A, Farquharson B, Siddiqui FJ, Banerjee A, Matsuyama T, Cheng A; Education Implementation Team Task Force of the International Liaison Committee on Resuscitation ILCOR. Use of CPR feedback devices in resuscitation training: A systematic review and meta-analysis of randomized controlled trials. Resusc Plus. 2025 Mar 22;23:100939. doi: 10.1016/j.resplu.2025.100939. eCollection 2025 May.
Zapletal B, Greif R, Stumpf D, Nierscher FJ, Frantal S, Haugk M, Ruetzler K, Schlimp C, Fischer H. Comparing three CPR feedback devices and standard BLS in a single rescuer scenario: a randomised simulation study. Resuscitation. 2014 Apr;85(4):560-6. doi: 10.1016/j.resuscitation.2013.10.028. Epub 2013 Nov 8.
Szarpak L, Bogdanski L, Czyzewski L, Zasko P, Kurowski A. Are chest compressions using the TrueCPR feedback device more effective than manual compressions during pediatric resuscitation? A randomized controlled trial. Indian Journal of Research. 2015; 4(1):84-86.
Wutzler A, Bannehr M, von Ulmenstein S, Loehr L, Forster J, Kuhnle Y, Finn A, Storm C, Haverkamp W. Performance of chest compressions with the use of a new audio-visual feedback device: a randomized manikin study in health care professionals. Resuscitation. 2015 Feb;87:81-5. doi: 10.1016/j.resuscitation.2014.10.004. Epub 2014 Oct 17.
Kurowski A, Szarpak L, Bogdanski L, Zasko P, Czyzewski L. Comparison of the effectiveness of cardiopulmonary resuscitation with standard manual chest compressions and the use of TrueCPR and PocketCPR feedback devices. Kardiol Pol. 2015;73(10):924-30. doi: 10.5603/KP.a2015.0084. Epub 2015 May 19.
Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.
Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
Related Links
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Smereka J, Szarpak L, Czekajlo M, Abelson A, Zwolinski P, Plusa T, et al. The TrueCPR device in the process of teaching cardiopulmonary resuscitation: A randomized simulation trial. Medicine (Baltimore). 2019 Jul;98(27):e15995.
Other Identifiers
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KA16/73
Identifier Type: -
Identifier Source: org_study_id
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