NCT01446471

Brief Summary

The aim of this study is to investigate the predictive value of the presence or absence of cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate based on previous research that patients who suffer a cardiac arrest and have cardiac activity on bedside ultrasound will have a greater chance of surviving to hospital admission. The investigators hypothesis is that the mortality rate in patients in cardiac arrest with no cardiac activity by ultrasound will have a mortality rate of 100%.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

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

January 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

September 9, 2011

Last Update Submit

November 30, 2015

Conditions

Keywords

Bedside UltrasoundPoint of care ultrasoundcardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Number of patients that survive to Hospital Discharge

    Participants will be followed for the duration of hospital stay, an expected average of up to 12 months. The time frame is an estimate based on previous research. Patients could survive hours to days to weeks or months.

    Up to 12 months

Secondary Outcomes (2)

  • The number of patients that demonstrate a Return of Spontaneous Circulation

    Up to 60 Minutes -

  • The number of patients that survive to hospital admission

    Up to 24 hours

Study Arms (1)

Cardiac Arrest

Patients in Cardiac Arrest will be enrolled

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in cardiac arrest

You may qualify if:

  • Patients in cardiac arrest with no pulse

You may not qualify if:

  • Patients with isolated ventricular fibrillation as their cardiac rhythm at the time of presentation
  • Traumatic cardiopulmonary arrest
  • Ultrasound system or physician experienced in bedside cardiac ultrasound not available
  • Resuscitative efforts halted due to end of life decisions or designations
  • Attending physician of record declines enrollment of patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Christiana Health Care

Newark, Delaware, 19718, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Washington University Hospital

St Louis, Missouri, 63130, United States

Location

Northshore University Hospital

Manhasset, New York, 11030, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University of Ottowa

Ottowa, Canada

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Romolo Gaspari, MD, PhD

    UMass Memorial Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Emergency Ultrsound

Study Record Dates

First Submitted

September 9, 2011

First Posted

October 5, 2011

Study Start

January 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations