NCT04149730

Brief Summary

This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type of cardiac arrest. ECG changes may be useful as a prognostic marker during resuscitation from PEA. In addition the researchers will describe the effect of adrenaline and chest compressions on clinical state transitions during resuscitation from pulseless electrical activity. Clinical state transitions are changes between different types of cardiac arrest. This study is expected to increase our understanding of the dynamics during treatment of cardiac arrest.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

October 18, 2019

Last Update Submit

September 1, 2023

Conditions

Keywords

EpinephrinePulseless electrical activity

Outcome Measures

Primary Outcomes (3)

  • QRS frequency

    Measurement of RR intervals in milliseconds.

    Every 3 minutes from start till end of cardiopulmonary resuscitation

  • QRS width

    Measurement of the width of QRS complexes in milliseconds

    Every 3 minutes from start till end of cardiopulmonary resuscitation

  • Changes of clinical states

    changes of clinical states (for example from Pulseless electrical activity to Ventricular fibrillation) during treatment of cardiac arrest.

    Every 3 minutes from start till end of cardiopulmonary resuscitation

Study Arms (1)

Patients with primary PEA.

Patients at St. Olavs hospital who suffer cardiac arrest and pulseless electrical activity (PEA) as primary rhythm during 2018-2021. 120 episodes from St. Olavs hospital were collected previously (2010-2013). In addition 200 cases will be available from the hospital of The University of Pennsylvania, Philadelphia, USA.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will consist of patients suffering cardiac arrest while being hospitalized at St. Olavs hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Eirik Skogvoll, md prof

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

November 4, 2019

Study Start

March 20, 2019

Primary Completion

January 1, 2023

Study Completion

May 15, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations