Effectiveness of Chest Compressions With Standard vs Feedback-Assisted CPR

NCT07029724 | Completed

• 1 other identifier: KA16/73
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

CPR Quality Assessment

Keywords

CPR quality; clinical training; emergency medicine; feedback device; simulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From randomization until the end of the chest compression sessions, within a 60-minute period.

Study Arms (2)

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.

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.

Device: TrueCPR Multisensory Feedback Device; Device: Ambu Smartman ALS Pro+ (AW301) Simulation Manikin

Interventions

TrueCPR Multisensory Feedback Device 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.

Group 2: Standard-to-TrueCPR Group

Ambu Smartman ALS Pro+ (AW301) Simulation Manikin DEVICE

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.

Group 1: Standard-to-Metronome Group; Group 2: Standard-to-TrueCPR Group

Metronome DEVICE

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 1: Standard-to-Metronome Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betül Akbuğa Özel: lead
• Baskent University: collaborator

Study Sites (2)

Ankara Bilkent City Hospital, Ankara Yıldırım Beyazıt University, Faculty of Medicine, of Emergency Medicine

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

Başkent University

Etimesgut, Ankara, 06790, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 31277091 BACKGROUND

• 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.

  PMID: 40230367 BACKGROUND

• 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.

  PMID: 24215730 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25449342 BACKGROUND

• 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.

  PMID: 25985725 BACKGROUND

• 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.

  PMID: 26612703 BACKGROUND

• 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.

  PMID: 33081529 BACKGROUND

Related Links

• 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.

Study Officials

• Betül Akbuğa Özel, Asst. Prof.

  Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara Bilkent City Hospital, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was maintained during data analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, MD, FTBEM, MSc, PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: April 22, 2016
• Primary Completion: May 2, 2016
• Study Completion: May 2, 2016
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)