NCT04569812

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

September 9, 2019

Last Update Submit

September 29, 2020

Conditions

Keywords

ManikinsBystanderQuality

Outcome Measures

Primary Outcomes (1)

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

    correct compression depth according to ERC Guideline 2015

    During 5 minutes CPR

Secondary Outcomes (10)

  • hand-off time

    During 5 minutes CPR

  • time to the administration of CCs

    During 5 minutes CPR

  • total number of CCs

    During 5 minutes CPR

  • relative number of correct CCs (%)

    During 5 minutes CPR

  • During 5 minutes CPR

    During 5 minute CPR

  • +5 more secondary outcomes

Study Arms (2)

Standard CPR

EXPERIMENTAL

After 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

Procedure: Cardiopulmonary Resuscitation

Chest compressions only

EXPERIMENTAL

After 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

Procedure: Cardiopulmonary Resuscitation

Interventions

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

Chest compressions onlyStandard CPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers of non-medical professions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (8)

  • 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.

    PMID: 9508543BACKGROUND
  • 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.

    PMID: 26061835BACKGROUND
  • 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.

    PMID: 8214853BACKGROUND
  • 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.

    PMID: 28147412BACKGROUND
  • 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.

    PMID: 21333434BACKGROUND
  • 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.

    PMID: 26477420BACKGROUND
  • 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.

    PMID: 20951422BACKGROUND
  • 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.

    PMID: 23306815BACKGROUND

MeSH Terms

Interventions

Cardiopulmonary Resuscitation

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Officials

  • Bernhard Roessler, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 30, 2020

Study Start

March 23, 2015

Primary Completion

April 20, 2016

Study Completion

April 20, 2016

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations