CPR Quality AssessmentNCT07029724
Effectiveness of Chest Compressions With Standard vs Feedback-Assisted CPR
A study testing TrueCPR Multisensory Feedback Device, Ambu Smartman ALS Pro+ (AW301) Simulation Manikin and Metronome in people with CPR Quality Assessment, run by Betül Akbuğa Özel at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CPR Quality Assessment
- What is being tested?
- TrueCPR Multisensory Feedback Device, Ambu Smartman ALS Pro+ (AW301) Simulation Manikin and Metronome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Apr 2016to 2 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Bilkent City Hospital, Ankara Yıldırım Beyazıt University, Faculty of Medicine, of Emergency Medicine
Çankaya, Ankara, 06800
Başkent University
Etimesgut, Ankara, 06790
About this study
Official title: Comparison of Standard CPR and CPR Feedback Devices in Terms of the Effectiveness of Chest Compressions During Cardiopulmonary Resuscitation
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:
Read more
- 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.
Read the detailed description
- 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.
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.
- 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
- 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.
- 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.
- 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.
- 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
- CPR Quality Assessment
- Being tested
- TrueCPR Multisensory Feedback Device, Ambu Smartman ALS Pro+ (AW301) Simulation Manikin, Metronome
- Keywords
- CPR quality, clinical training, emergency medicine, feedback device, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueCPR Multisensory Feedback DeviceDevice
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 ManikinDevice
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.
MetronomeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard-to-Metronome Group | Experimental | 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. Receives: Device: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin; Device: Metronome |
| Group 2: Standard-to-TrueCPR Group | Experimental | 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. Receives: Device: TrueCPR Multisensory Feedback Device; Device: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compression rate
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.
Measured: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
Chest compression depth
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.
Measured: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.
Leaning percent
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.
Measured: From randomization until the end of the chest compression sessions, within a 60-minute period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start22 Apr 2016
- Primary completion2 May 2016
- Study completion2 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CPR Quality AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study is a randomized trial comparing standard CPR, metronome-guided CPR, and feedback device-assisted CPR (TrueCPR) to enhance the effectiveness of CPR in emergency medicine clinical skills training. It was designed as a single-center, parallel-group, open-label randomized trial. The study design and participant flow diagram were structured in accordance with the CONSORT 2010 guidelines.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betül Akbuğa Özel
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, Betül Akbuğa Özel, Ankara City Hospital Bilkent
- Investigators
- Betül Akbuğa Özel, Asst. Prof., Principal investigator, Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029724
- Sponsor's protocol ID
- KA16/73
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD). As the data are the property of Başkent University, any decision regarding access must be made at the institutional level. During the publication process of the study, IPD may be shared upon request to the principal investigator and is subject to institutional approval.
Publications
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.
PubMed 31277091Lin 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.
PubMed 40230367Zapletal 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.
PubMed 24215730Szarpak 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.
PubMed 25449342Kurowski 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.
PubMed 25985725Truszewski 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.
PubMed 26612703Panchal 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.
PubMed 33081529
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard CPR and CPR Feedback Devices in Terms of the Effectiveness of Chest Compressions During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT07029724
- Acronym / sponsor ID
- KA16/73
- Conditions
- CPR Quality Assessment
- Keywords
- CPR quality, clinical training, emergency medicine, feedback device, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Betül Akbuğa ÖzelUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 2 May 2016 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
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.
- 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
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study is a randomized trial comparing standard CPR, metronome-guided CPR, and feedback device-assisted CPR (TrueCPR) to enhance the effectiveness of CPR in emergency medicine clinical skills training. It was designed as a single-center, parallel-group, open-label randomized trial. The study design and participant flow diagram were structured in accordance with the CONSORT 2010 guidelines.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard-to-Metronome Group | Experimental | Device: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin, Device: MetronomeThe 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. |
| Group 2: Standard-to-TrueCPR Group | Experimental | Device: TrueCPR Multisensory Feedback Device, Device: Ambu Smartman ALS Pro+ (AW301) Simulation ManikinThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrueCPR Multisensory Feedback DeviceTrueCPR (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. | Device | Group 2: Standard-to-TrueCPR Group |
| Ambu Smartman ALS Pro+ (AW301) Simulation ManikinThe 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. | Device | Group 1: Standard-to-Metronome Group, Group 2: Standard-to-TrueCPR Group |
| MetronomeThe 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. | Device | Group 1: Standard-to-Metronome Group |
Primary outcome
Chest compression rate
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Results publication: PubMed 31277091Smereka 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.
- Results publication: PubMed 40230367Lin 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.
- Results publication: PubMed 24215730Zapletal 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.
- Results publicationSzarpak 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.
- Results publication: PubMed 25449342Wutzler 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.
- Results publication: PubMed 25985725Kurowski 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.
- Results publication: PubMed 26612703Truszewski 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.
- Results publication: PubMed 33081529Panchal 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD). As the data are the property of Başkent University, any decision regarding access must be made at the institutional level. During the publication process of the study, IPD may be shared upon request to the principal investigator and is subject to institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Akbuğa Özel, Asst. Prof. principal investigator
Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrueCPR Multisensory Feedback Device, Ambu Smartman ALS Pro+ (AW301) Simulation Manikin and Metronome in people with CPR Quality Assessment, run by Betül Akbuğa Özel at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest compression rate (time frame: From randomization to the completion of all chest compression procedures, within a maximum duration of 60 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029724, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.