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Cardiopulmonary ResuscitationNCT04569812

Standard CPR Versus Chest Compressions Only

A study testing Cardiopulmonary Resuscitation in people with Cardiopulmonary Resuscitation, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: More than two thirds of sudden cardiac arrests are witnessed by bystanders. Bystander cardiopulmonary resuscitation (CPR) doubles survival from cardiac arrest. Importantly, even in witnessed cardiac arrests only 20% of the bystanders commence basic life support. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiopulmonary Resuscitation
What is being tested?
Cardiopulmonary Resuscitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteAustria
Study dates
23 Mar 2015to 20 Apr 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Volunteers of non-medical professions

Who cannot join

  • <18years
  • medical professionals
  • known pregnancy
  • physical impairments or illnesses that prohibited physical

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Providing the Best Chest Compression Quality: Standard CPR Versus Chest Compressions Only in a Bystander Resuscitation Model.

Background:

More than two thirds of sudden cardiac arrests are witnessed by bystanders. Bystander cardiopulmonary resuscitation (CPR) doubles survival from cardiac arrest. Importantly, even in witnessed cardiac arrests only 20% of the bystanders commence basic life support. Common reasons for not commencing include panicking and the perceived inability to perform CPR correctly. A meta-analysis could demonstrate that a simplification of the algorithm (compression-only dispatcher-assisted bystander CPR) led to a 22% increase in survival-to-hospital discharge. A recently published trial of the research group could demonstrate that the presence of a flowchart has a positive effect on the quality of BLS while at the same time increasing the rescuers' confidence. Nonetheless, performing CPR is exhausting. Previous publications have emphasized increasing fatigue with the duration of CPR efforts in both, standard and chest compressions-only CPR. Consequently, the investigators wanted to test the hypothesis that chest compressions (CC) are delivered more correctly regarding the depth when utilizing the standard Basic Life Support (BLS) algorithm with the aid of a flowchart as compared to the CC only algorithm utilizing an adapted CPR flowchart in a manikin resuscitation model.

Read more

Methods:

After consent of the Research Ethics Board of Medical University of Vienna and obtaining written informed consent of the participants, 84 medically untrained laypersons will be randomised to perform flow-chart assisted CPR for 300s following standard CPR guidelines or CC only CPR. The primary outcome parameter will be the total number of CC achieving the correct depth of 50-60mm. Secondary outcome parameters will be hands-off time, the total number of CC, and the compression rate. The total number of delivered rescue breaths, tidal volume, and time to deliver these will also be evaluated. Furthermore, the subjective point of exhaustion affecting the CPR quality, the reason for discontinuation of CPR if stopped within the 300sec. period and the exhaustion at the end of the CPR measures will be evaluated.

Read the detailed description

Volunteers will be invited to participate in the trial by the study personnel. Recruitment will be conducted at a Training Centre of St. John ambulance, Vienna, Austria, before the starts of the lessons. After giving written informed consent, participants will be randomized using a web based randomization program (www.random.org) and allocated to perform standard CPR or CC only. The randomization for group allocation will be kept in opaque and sealed envelopes.

The evaluation will be performed with an independent investigator using a computer attached Resusci-Anne Skillreporter by Laerdal-Medical® and the Laerdal Skillreporter Software with Segstat (Version 2.3.0, Laerdal Medical, Stavanger, Norway).

The participants will be asked to perform BLS for five minutes on a manikin. The participants will then be asked to undertake any action they deem necessary to rescue the person simulated by the resuscitation manikin. Participants will not be informed about the underlying hypothesis or the outcome parameters. The room will be prepared to minimise outside interruptions.

Additionally, participants will be instructed to indicate the point in time during CPR when they feel that their fatigue is affecting the quality of the life support performed. ("During CPR and without stopping your actions, please tell us "NOW" when you perceive your fatigue is affecting the quality of the life support performed.)

Participants in both groups will receive one of the charts right at the beginning of the scenario with the information that "this chart will provide information on how to perform CPR" and with the start of the clock further instructions regarding is content. Both groups will not receive any further introduction or support. At the beginning of the scenario, the manikin will be positioned in a supine position on the floor. There will be no clock visible for the participant while performing CPR. An investigator is acting as bystander able to call the emergency medical service or to be sent to look for an automated external defibrillator (which will not be available in the scenario). Nonetheless, the investigator is instructed not to provide any information on how to perform CPR and does not physically take part in the primary check, CC, or mouth-to-mouth ventilations.

Data of steps performed or left out will be documented in hardcopy on the case report form by an investigator and the exact times and details of chest compressions and ventilations will be documented electronically (Laerdal Skillreporter Software with Segstat (Version 2.3.0, Laerdal Medical, Stavanger, Norway)). Checklists of necessary steps will be created based on the European Resuscitation Council (ERC) BLS Guidelines 2010 in the same manner as published previously [Roessler et al. 2007, Koster et al. 2010].

After the five-minute period has ended, the participants will be informed that the emergency medical service is now taking over and that they can stop performing CPR. Directly thereafter, they will be asked the following questions "How exhausted are you now on a scale from 1 to 10, where 1 indicates no exhaustion at all and 10 maximum exhaustion?" (Lickert Like 1-10). If a participant chooses to abort resuscitation attempts before the five minutes are over, the open-ended question "Why did you discontinue the resuscitation attempts?" will be raised.

Being tested
Cardiopulmonary Resuscitation
Keywords
Manikins, Bystander, Quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiopulmonary ResuscitationProcedure or surgery

    flowchart-assisted standard resuscitation or chest compressions-only resuscitation for 5min

Study groups in NCT04569812
Study groupRoleWhat they receive
Standard CPRExperimentalAfter Informed Consent Document (ICD) signature, participants were randomised (to the Standard CPR group) to perform standard CPR (30:2) in a flowchart-assisted resuscitation for 5min in a manikin model
Receives: Procedure: Cardiopulmonary Resuscitation
Chest compressions onlyExperimentalAfter ICD signature, participants were randomised (to the CC only CPR group) to perform chest compressions only in a flowchart-assisted resuscitation for 5min in a manikin model
Receives: Procedure: Cardiopulmonary Resuscitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total number of CCs that achieved the correct depth of 5-6cm

    correct compression depth according to ERC Guideline 2015

    Measured: During 5 minutes CPR

Secondary outcomes (10)
  1. hand-off time

    defined as the sum of the total time in which no CCs were provided

    Measured: During 5 minutes CPR

  2. time to the administration of CCs

    Interval from cardiac arrest to start of chest compressions

    Measured: During 5 minutes CPR

  3. total number of CCs

    Total number of chest compressions delivered

    Measured: During 5 minutes CPR

  4. relative number of correct CCs (%)

    Percentage of chest compressions delivered at the correct depth

    Measured: During 5 minutes CPR

  5. During 5 minutes CPR

    chest compressions delivered at a depth of >5cm

    Measured: During 5 minute CPR

  6. relative number of CCs >5cm

    percentage of chest compressions delivered at a depth of >5cm

    Measured: During 5 minutes CPR

  7. average compression rate

    average rate of chest compressions (X/minute)

    Measured: During 5 minutes CPR

  8. Time to fatigue

    Interval to the timepoint when participants subjectively felt a loss in the quality of CPR due to fatigue

    Measured: During 5 minutes CPR

  9. levels of confidence

    10-item Likert-like scale

    Measured: During 5 minutes CPR

  10. levels of exhaustion

    Exhaustion after 5 minutes of CPR (10-item Likert-like scale)

    Measured: During 5 minutes CPR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start23 Mar 2015
  3. Primary completion20 Apr 2016
  4. Study completion20 Apr 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized controlled study
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04569812
Sponsor's protocol ID
1136/2015
Status last verified
Sep 2020
First submitted
9 Sep 2019
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sans S, Kesteloot H, Kromhout D. The burden of cardiovascular diseases mortality in Europe. Task Force of the European Society of Cardiology on Cardiovascular Mortality and Morbidity Statistics in Europe. Eur Heart J. 1997 Dec;18(12):1231-48. No abstract available.

    PubMed 9508543
  • Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.

    PubMed 26061835
  • Larsen MP, Eisenberg MS, Cummins RO, Hallstrom AP. Predicting survival from out-of-hospital cardiac arrest: a graphic model. Ann Emerg Med. 1993 Nov;22(11):1652-8. doi: 10.1016/s0196-0644(05)81302-2.

    PubMed 8214853
  • Nolan JP. Cardiac Arrest and Cardiopulmonary Resuscitation. Semin Neurol. 2017 Feb;37(1):5-12. doi: 10.1055/s-0036-1597832. Epub 2017 Feb 1.

    PubMed 28147412
  • Savastano S, Vanni V. Cardiopulmonary resuscitation in real life: the most frequent fears of lay rescuers. Resuscitation. 2011 May;82(5):568-71. doi: 10.1016/j.resuscitation.2010.12.010. Epub 2011 Feb 17.

    PubMed 21333434
  • Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.

    PubMed 26477420
  • Hupfl M, Selig HF, Nagele P. Chest-compression-only versus standard cardiopulmonary resuscitation: a meta-analysis. Lancet. 2010 Nov 6;376(9752):1552-7. doi: 10.1016/S0140-6736(10)61454-7. Epub 2010 Oct 14.

    PubMed 20951422
  • Rossler B, Ziegler M, Hupfl M, Fleischhackl R, Krychtiuk KA, Schebesta K. Can a flowchart improve the quality of bystander cardiopulmonary resuscitation? Resuscitation. 2013 Jul;84(7):982-6. doi: 10.1016/j.resuscitation.2013.01.001. Epub 2013 Jan 7.

    PubMed 23306815

Questions about this trial

What is this clinical trial studying?

A study testing Cardiopulmonary Resuscitation in people with Cardiopulmonary Resuscitation, run by Medical University of Vienna at 1 site in Austria.

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 4 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

total number of CCs that achieved the correct depth of 5-6cm (time frame: During 5 minutes CPR). 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 NCT04569812, 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 1 Oct 2020.

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