NCT01245699

Brief Summary

The investigators will quantify the quality of chest compressions provided in the Emergency Department and determine whether the quality of chest compressions is related to patient outcome. The quality of chest compressions and patient outcomes will be assessed both before and after the introduction of audiovisual feedback in real time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

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

Study Start

First participant enrolled

June 9, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

January 1, 2019

Enrollment Period

5.4 years

First QC Date

November 19, 2010

Results QC Date

October 12, 2017

Last Update Submit

April 25, 2019

Conditions

Keywords

Cardiac arrest, CPR, quality improvement

Outcome Measures

Primary Outcomes (6)

  • CPR Quality-compression Depth

    Measurement of chest compression depth

    during CPR

  • CPR Quality-percent of >51mm Compressions

    Percent of Chest Compressions greater than 51mm

    during CPR

  • CPR Quality

    Chest Compression Release Velocity

    during CPR

  • CPR Quality-compression Fraction

    Chest Compression Fraction indicating the percentage of time in which chest compressions are done by rescuers during a cardiac arrest

    During CPR

  • CPR Quality-Chest Compression Rate

    Mean Chest Compression Rate

    During CPR

  • CPR Quality- Pre-shock Pause

    Pre-shock pause: time from cessation of CPR to shock delivery

    During CPR

Study Arms (2)

Before RTAVF and post-event debriefing

NO INTERVENTION

Before scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing

After RTAVF and post-event debriefing

ACTIVE COMPARATOR

After scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing

Behavioral: scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing

Interventions

scenario-based training for CPR, real-time audiovisual CPR feedback using R Series monitor-defibrillator during treatment, and post-event debriefing

After RTAVF and post-event debriefing

Eligibility Criteria

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

You may qualify if:

  • years old or older

You may not qualify if:

  • less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

Related Publications (1)

  • Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

11 study participants were eliminated because event data was not captured. A single-center, nonrandomized, non-blinded, study. The Hawthorne effect may have affected results. Variations in the level of training and proficiency of providers.

Results Point of Contact

Title
Bentley J Bobrow, MD
Organization
Maricopa Integrated Health System

Study Officials

  • Bentley J Bobrow, MD

    Valleywise Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Chest Compression before and after RealCPRHelp
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

June 9, 2010

Primary Completion

November 5, 2015

Study Completion

March 9, 2016

Last Updated

April 26, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-01

Locations