NCT02401633

Brief Summary

Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is a positive predictor of survival. During the last decade, the best form of bystander CPR has been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method in situations where the bystander has no previous knowledge in CPR, both because its believed to be equally efficient but also a simplified form of CPR that could lead to a higher incidence of bystander-CPR. The purpose of this study is to perform av run-in period with focus on safety and feasibility prior to the launch of a larger randomized trial which has a primary end-point of survival. This study will compare OHCA with standard CPR (S-CPR; chest compressions and rescue breaths in a 30:2 fashion) compared to CO-CPR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 7, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

5.2 years

First QC Date

March 7, 2015

Last Update Submit

September 15, 2022

Conditions

Cardiac ArrestOut of Hospital Cardiac Arrest

Keywords

Cardio-Pulmonary-ResuscitationAdvanced Cardiac Life SupportCompression-Only CPRChest compression CPR

Outcome Measures

Primary Outcomes (2)

  • Descriptive measurement of feasibility

    * Evaluation of automated inclusion and randomization * Evaluation of information of allocation to bystander * Adherence to the two protocol, bystanders (S-CPR/CO-CPR) * Validation of data collection and sources (please see appendix) * Sufficient inclusion of all OHCA during the RUN-IN study period

    6 months

  • Descriptive measurement of safety (delay CPR)

    * Delay to start of CPR due to screening for inclusion, exclusion, randomization and instructions to the witnesses (S-CPR/CO-CPR) * Correct inclusion * Correct exclusion * Proportion of patients correctly identified as cardiac arrests

    6 months

Secondary Outcomes (3)

  • Proportions of patients with ventricular fibrillation/ ventricular tachycardia (ITT and PP)

    within minutes from arrival of the EMS (day 1)

  • Proportion of patients who achieve return of spontaneous circulation (ROSC)

    day 1

  • Survival to hospital admission

    day 1

Study Arms (2)

CO-CPR Bystander

EXPERIMENTAL

Instructions by dispatcher to trained bystander to provide CPR with chest-compressions only

Procedure: CO-CPR

S-CPR Bystander

ACTIVE COMPARATOR

Instructions by dispatcher to trained bystander to provide CPR with chest-compressions and rescue breaths in a 30:2 ratio

Procedure: S-CPR

Interventions

CO-CPRPROCEDURE

CPR provided by bystander with chest-compressions only

Also known as: Compression only CPR, Continous Chest Compressions
CO-CPR Bystander
S-CPRPROCEDURE

CPR with Chest Compressions and Rescue Breaths in a ratio of 30:2

Also known as: Standard CPR
S-CPR Bystander

Eligibility Criteria

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

You may qualify if:

  • Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)
  • The suspected OHCA is witnessed (seen or heard)
  • Bystander has previous training in CPR

You may not qualify if:

  • Age 18 or younger
  • Collapse is not witnessed
  • Bystander has never been trained in CPR (these bystanders should be instructed to administer CO-CPR in accordance to guidelines).
  • Obvious asphyxia, i.e. drowning, strangulation, hanging
  • Obvious intoxication or drug overdose
  • Pregnancy
  • Obvious pregnancy
  • Trauma
  • Bystander is unwilling to participate or to perform CPR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm, Sweden

Stockholm, Sweden

Location

Related Publications (1)

  • Riva G, Boberg E, Ringh M, Jonsson M, Claesson A, Nord A, Rubertsson S, Blomberg H, Nordberg P, Forsberg S, Rosenqvist M, Svensson L, Andrell C, Herlitz J, Hollenberg J. Compression-Only or Standard Cardiopulmonary Resuscitation for Trained Laypersons in Out-of-Hospital Cardiac Arrest: A Nationwide Randomized Trial in Sweden. Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010027. doi: 10.1161/CIRCOUTCOMES.122.010027. Epub 2024 Mar 6.

    PMID: 38445487DERIVED

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jacob Hollenberg, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 7, 2015

First Posted

March 30, 2015

Study Start

January 1, 2017

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Data will be published on group level only

Locations

SE(1)