Cardiac ArrestNCT02511470
Use of a Metronome in Cardiopulmonary Resuscitation: A Simulation Study
A study testing Metronome on and Metronome off in people with Cardiac Arrest, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
Trial summary
The purpose of this study is to determine if the use of a metronome improves chest compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Metronome on and Metronome off
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jul 2014
- 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
- health professionals with a minimum of basic life support training according to the 2010 AHA guidelines capable of performing chest compressions.
Who cannot join
None listed.
About this study
Official title: The Use of an Audible Metronome Improves Chest Compression During Cardiopulmonary Resuscitation on a Pediatric Simulation Manikin
The purpose of this study is to determine if the use of a metronome improves chest compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin.
Read the detailed description
The study will be conducted in the simulation laboratory at Miami Children's Hospital. Chest compressions will be performed on a compression pediatric simulator. It will consist of two main groups randomly assigned to chest compressions without an audible metronome and chest compressions with audible metronomic tones that beep 100 times per minute for chest compressions. The metronome will be used to coach the correct rate. The same people will complete both arms of the study at one visit. Specifically, the participants will do 2 minutes of chest compressions followed by a 15-minute break then another 2 minutes of chest compressions (to avoid fatigue) with an acceptable range for rate 90-110 BPM and depth of 38-51mm. The subjects will be informed about the metronome, but will not be informed about the measured variables, such as rate and depth of chest compressions. However, the participants will be reminded at the beginning of their visit about the PALS card, i.e. appropriate rate and depth. The use of "talking people noise" from YouTube will be played in the background to fully model a cardiac arrest scenario (to see if participants ignore the metronome) and will be used during each group session. A noise dosimeter will be used to ensure this noise level is the same for each scenario. The manikin's airway will be secured with an endotracheal tube with continuous ventilations so chest compressions can be continued without interruption. Recommendations for chest compression rate and depth are per Pediatric Advanced Life Support (PALS) according to the 2010 American Heart Association (AHA) guidelines.
Data will be collected via the manikin which will wirelessly transmit the data (chest compression rate and depth) to a computer. The manikin has CPR sensing and recording technology software built in. This software records sternum movement depth and rate of chest compressions. Criteria for adequate CPR quality are defined as compression rate between 90-110 per minute and compression depth between 38-51mm.
- Conditions
- Cardiac Arrest
- Being tested
- Metronome on, Metronome off
- Keywords
- Cardiopulmonary Resuscitation, Pediatric simulation study, Metronome
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronome onOther
Metronome on during participants performance of CPR on a pediatric manikin
Metronome offOther
Metronome off during participants performance of CPR on a pediatric manikin
| Study group | Role | What they receive |
|---|---|---|
| CPR with metronome on | Other | Participants will perform two minutes of uninterrupted chest compressions on a pediatric manikin with the metronome on. Data for compression rate and depth will be collected during this time interval. Receives: Other: Metronome on |
| CPR with metronome off | Other | Participants will perform two minutes of uninterrupted chest compressions on a pediatric manikin with the metronome off. Data for compression rate and depth will be collected during this time interval. Receives: Other: Metronome off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metronome effect on compression rate and depth
The mean of the percentage of compressions that were within an adequate rate (90-110 per minute) and adequate depth (38-51mm) with and without the metronome.
Measured: Adequacy of chest compressions (in terms of rate and depth) under each intervention (with and without metronome) was assessed during two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Sponsor
- Investigators
- Marc Linares, MD, Principal investigator, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511470
- Sponsor's protocol ID
- 1-806360-1
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abella BS, Sandbo N, Vassilatos P, Alvarado JP, O'Hearn N, Wigder HN, Hoffman P, Tynus K, Vanden Hoek TL, Becker LB. Chest compression rates during cardiopulmonary resuscitation are suboptimal: a prospective study during in-hospital cardiac arrest. Circulation. 2005 Feb 1;111(4):428-34. doi: 10.1161/01.CIR.0000153811.84257.59.
PubMed 15687130Al-Shamsi M, Al-Qurashi W, de Caen A, Bhanji F. Pediatric basic and advanced life support: an update on practice and education. Oman Med J. 2012 Nov;27(6):450-4. doi: 10.5001/omj.2012.108.
PubMed 23226814Bohn A, Weber TP, Wecker S, Harding U, Osada N, Van Aken H, Lukas RP. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation. 2011 Mar;82(3):257-62. doi: 10.1016/j.resuscitation.2010.11.006. Epub 2010 Dec 13.
PubMed 21146279Dine CJ, Gersh RE, Leary M, Riegel BJ, Bellini LM, Abella BS. Improving cardiopulmonary resuscitation quality and resuscitation training by combining audiovisual feedback and debriefing. Crit Care Med. 2008 Oct;36(10):2817-22. doi: 10.1097/CCM.0b013e318186fe37.
PubMed 18766092Fitzgerald KR, Babbs CF, Frissora HA, Davis RW, Silver DI. Cardiac output during cardiopulmonary resuscitation at various compression rates and durations. Am J Physiol. 1981 Sep;241(3):H442-8. doi: 10.1152/ajpheart.1981.241.3.H442.
PubMed 7282953Handley AJ, Handley SA. Improving CPR performance using an audible feedback system suitable for incorporation into an automated external defibrillator. Resuscitation. 2003 Apr;57(1):57-62. doi: 10.1016/s0300-9572(02)00400-8.
PubMed 12668300Hurst VW 4th, Whittam SW, Austin PN, Branson RD, Beck G. Cardiopulmonary resuscitation during spaceflight: examining the role of timing devices. Aviat Space Environ Med. 2011 Aug;82(8):810-3. doi: 10.3357/asem.2284.2011.
PubMed 21853860Jantti H, Silfvast T, Turpeinen A, Kiviniemi V, Uusaro A. Influence of chest compression rate guidance on the quality of cardiopulmonary resuscitation performed on manikins. Resuscitation. 2009 Apr;80(4):453-7. doi: 10.1016/j.resuscitation.2009.01.001. Epub 2009 Feb 8.
PubMed 19203821Kern KB, Hilwig RW, Berg RA, Ewy GA. Efficacy of chest compression-only BLS CPR in the presence of an occluded airway. Resuscitation. 1998 Dec;39(3):179-88. doi: 10.1016/s0300-9572(98)00141-5.
PubMed 10078808Kern KB. Cardiopulmonary resuscitation without ventilation. Crit Care Med. 2000 Nov;28(11 Suppl):N186-9. doi: 10.1097/00003246-200011001-00003.
PubMed 11098942Kern KB, Stickney RE, Gallison L, Smith RE. Metronome improves compression and ventilation rates during CPR on a manikin in a randomized trial. Resuscitation. 2010 Feb;81(2):206-10. doi: 10.1016/j.resuscitation.2009.10.015. Epub 2009 Nov 18.
PubMed 19926194Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL. Part 14: pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S876-908. doi: 10.1161/CIRCULATIONAHA.110.971101. No abstract available.
PubMed 20956230Kramer-Johansen J, Myklebust H, Wik L, Fellows B, Svensson L, Sorebo H, Steen PA. Quality of out-of-hospital cardiopulmonary resuscitation with real time automated feedback: a prospective interventional study. Resuscitation. 2006 Dec;71(3):283-92. doi: 10.1016/j.resuscitation.2006.05.011. Epub 2006 Oct 27.
PubMed 17070980Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
PubMed 23339874Milander MM, Hiscok PS, Sanders AB, Kern KB, Berg RA, Ewy GA. Chest compression and ventilation rates during cardiopulmonary resuscitation: the effects of audible tone guidance. Acad Emerg Med. 1995 Aug;2(8):708-13. doi: 10.1111/j.1553-2712.1995.tb03622.x.
PubMed 7584749
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Audible Metronome Improves Chest Compression During Cardiopulmonary Resuscitation on a Pediatric Simulation Manikin
- ClinicalTrials.gov ID
- NCT02511470
- Acronym / sponsor ID
- 1-806360-1
- Conditions
- Cardiac Arrest
- Keywords
- Cardiopulmonary Resuscitation, Pediatric simulation study, Metronome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jul 2015 (estimated)
- 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 purpose of this study is to determine if the use of a metronome improves chest compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin.
Detailed description
The study will be conducted in the simulation laboratory at Miami Children's Hospital. Chest compressions will be performed on a compression pediatric simulator. It will consist of two main groups randomly assigned to chest compressions without an audible metronome and chest compressions with audible metronomic tones that beep 100 times per minute for chest compressions. The metronome will be used to coach the correct rate. The same people will complete both arms of the study at one visit. Specifically, the participants will do 2 minutes of chest compressions followed by a 15-minute break then another 2 minutes of chest compressions (to avoid fatigue) with an acceptable range for rate 90-110 BPM and depth of 38-51mm. The subjects will be informed about the metronome, but will not be informed about the measured variables, such as rate and depth of chest compressions. However, the participants will be reminded at the beginning of their visit about the PALS card, i.e. appropriate rate and depth. The use of "talking people noise" from YouTube will be played in the background to fully model a cardiac arrest scenario (to see if participants ignore the metronome) and will be used during each group session. A noise dosimeter will be used to ensure this noise level is the same for each scenario. The manikin's airway will be secured with an endotracheal tube with continuous ventilations so chest compressions can be continued without interruption. Recommendations for chest compression rate and depth are per Pediatric Advanced Life Support (PALS) according to the 2010 American Heart Association (AHA) guidelines.
Data will be collected via the manikin which will wirelessly transmit the data (chest compression rate and depth) to a computer. The manikin has CPR sensing and recording technology software built in. This software records sternum movement depth and rate of chest compressions. Criteria for adequate CPR quality are defined as compression rate between 90-110 per minute and compression depth between 38-51mm.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPR with metronome on | Other | Other: Metronome onParticipants will perform two minutes of uninterrupted chest compressions on a pediatric manikin with the metronome on. Data for compression rate and depth will be collected during this time interval. |
| CPR with metronome off | Other | Other: Metronome offParticipants will perform two minutes of uninterrupted chest compressions on a pediatric manikin with the metronome off. Data for compression rate and depth will be collected during this time interval. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- health professionals with a minimum of basic life support training according to the 2010 AHA guidelines capable of performing chest compressions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Metronome onMetronome on during participants performance of CPR on a pediatric manikin | Other | CPR with metronome on |
| Metronome offMetronome off during participants performance of CPR on a pediatric manikin | Other | CPR with metronome off |
Primary outcome
Metronome effect on compression rate and depth
Time frame: Adequacy of chest compressions (in terms of rate and depth) under each intervention (with and without metronome) was assessed during two minutes
The mean of the percentage of compressions that were within an adequate rate (90-110 per minute) and adequate depth (38-51mm) with and without the metronome.
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 30 Jul 2015.
- Background: PubMed 15687130Abella BS, Sandbo N, Vassilatos P, Alvarado JP, O'Hearn N, Wigder HN, Hoffman P, Tynus K, Vanden Hoek TL, Becker LB. Chest compression rates during cardiopulmonary resuscitation are suboptimal: a prospective study during in-hospital cardiac arrest. Circulation. 2005 Feb 1;111(4):428-34. doi: 10.1161/01.CIR.0000153811.84257.59.
- Background: PubMed 23226814Al-Shamsi M, Al-Qurashi W, de Caen A, Bhanji F. Pediatric basic and advanced life support: an update on practice and education. Oman Med J. 2012 Nov;27(6):450-4. doi: 10.5001/omj.2012.108.
- Background: PubMed 21146279Bohn A, Weber TP, Wecker S, Harding U, Osada N, Van Aken H, Lukas RP. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation. 2011 Mar;82(3):257-62. doi: 10.1016/j.resuscitation.2010.11.006. Epub 2010 Dec 13.
- Background: PubMed 18766092Dine CJ, Gersh RE, Leary M, Riegel BJ, Bellini LM, Abella BS. Improving cardiopulmonary resuscitation quality and resuscitation training by combining audiovisual feedback and debriefing. Crit Care Med. 2008 Oct;36(10):2817-22. doi: 10.1097/CCM.0b013e318186fe37.
- Background: PubMed 7282953Fitzgerald KR, Babbs CF, Frissora HA, Davis RW, Silver DI. Cardiac output during cardiopulmonary resuscitation at various compression rates and durations. Am J Physiol. 1981 Sep;241(3):H442-8. doi: 10.1152/ajpheart.1981.241.3.H442.
- Background: PubMed 12668300Handley AJ, Handley SA. Improving CPR performance using an audible feedback system suitable for incorporation into an automated external defibrillator. Resuscitation. 2003 Apr;57(1):57-62. doi: 10.1016/s0300-9572(02)00400-8.
- Background: PubMed 21853860Hurst VW 4th, Whittam SW, Austin PN, Branson RD, Beck G. Cardiopulmonary resuscitation during spaceflight: examining the role of timing devices. Aviat Space Environ Med. 2011 Aug;82(8):810-3. doi: 10.3357/asem.2284.2011.
- Background: PubMed 19203821Jantti H, Silfvast T, Turpeinen A, Kiviniemi V, Uusaro A. Influence of chest compression rate guidance on the quality of cardiopulmonary resuscitation performed on manikins. Resuscitation. 2009 Apr;80(4):453-7. doi: 10.1016/j.resuscitation.2009.01.001. Epub 2009 Feb 8.
- Background: PubMed 10078808Kern KB, Hilwig RW, Berg RA, Ewy GA. Efficacy of chest compression-only BLS CPR in the presence of an occluded airway. Resuscitation. 1998 Dec;39(3):179-88. doi: 10.1016/s0300-9572(98)00141-5.
- Background: PubMed 11098942Kern KB. Cardiopulmonary resuscitation without ventilation. Crit Care Med. 2000 Nov;28(11 Suppl):N186-9. doi: 10.1097/00003246-200011001-00003.
- Background: PubMed 19926194Kern KB, Stickney RE, Gallison L, Smith RE. Metronome improves compression and ventilation rates during CPR on a manikin in a randomized trial. Resuscitation. 2010 Feb;81(2):206-10. doi: 10.1016/j.resuscitation.2009.10.015. Epub 2009 Nov 18.
- Background: PubMed 20956230Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL. Part 14: pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S876-908. doi: 10.1161/CIRCULATIONAHA.110.971101. No abstract available.
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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.
Marc Linares, MD principal investigator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Metronome on and Metronome off in people with Cardiac Arrest, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
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 1 inclusion and 0 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Metronome effect on compression rate and depth (time frame: Adequacy of chest compressions (in terms of rate and depth) under each intervention (with and without metronome) was assessed during two minutes). 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 NCT02511470, which also lists 18 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 30 Jul 2015.