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OpenTrials
Completed

NCT Number: NCT04569812

Standard CPR Versus Chest Compressions Only

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers of non-medical professions

Exclusion criteria

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

Treatment and study plan

cardiopulmonary resuscitation

Procedure

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

Primary outcomes

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

    Time frame: During 5 minutes CPR

    correct compression depth according to ERC Guideline 2015

Secondary outcomes

  1. hand-off time

    Time frame: During 5 minutes CPR

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

  2. time to the administration of CCs

    Time frame: During 5 minutes CPR

    Interval from cardiac arrest to start of chest compressions

  3. total number of CCs

    Time frame: During 5 minutes CPR

    Total number of chest compressions delivered

  4. relative number of correct CCs (%)

    Time frame: During 5 minutes CPR

    Percentage of chest compressions delivered at the correct depth

  5. During 5 minutes CPR

    Time frame: During 5 minute CPR

    chest compressions delivered at a depth of >5cm

  6. relative number of CCs >5cm

    Time frame: During 5 minutes CPR

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

  7. average compression rate

    Time frame: During 5 minutes CPR

    average rate of chest compressions (X/minute)

  8. Time to fatigue

    Time frame: During 5 minutes CPR

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

  9. levels of confidence

    Time frame: During 5 minutes CPR

    10-item Likert-like scale

  10. levels of exhaustion

    Time frame: During 5 minutes CPR

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • St. John's Ambulance, Vienna Austria
  • Universitäres Simulationszentrum Wien, Klinik Floridsdorf, Vienna, Austria

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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