NCT00539539

Brief Summary

The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,586

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
2 countries

3 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

February 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 25, 2012

Completed
Last Updated

June 25, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

October 2, 2007

Results QC Date

December 30, 2010

Last Update Submit

May 21, 2012

Conditions

Heart Arrest

Outcome Measures

Primary Outcomes (1)

  • Rate of ROSC During the Prehospital Resuscitation

    Return of spontaneous circulation (ROSC)

    Prehospital resuscitation

Secondary Outcomes (7)

  • Pulses Present at ED Arrival.

    Resuscitation

  • Survival to Hospital Discharge

    Length of Hospitalization

  • CPR Fraction

    Up to 10 minutes of CPR

  • Compression Depth

    Up to 10 minutes of CPR

  • Compression Rate

    Up to 10 minutes of CPR

  • +2 more secondary outcomes

Study Arms (2)

Feedback On

ACTIVE COMPARATOR

Automated real-time feedback on CPR Process activated

Other: Laerdal Q-CPR /technology

Feedback Off

NO INTERVENTION

For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.

Interventions

Laerdal Q-CPR /technologyOTHER

For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.

Feedback On

Eligibility Criteria

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

You may qualify if:

  • all individuals who experience cardiac arrest outside the hospital,
  • are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.

You may not qualify if:

  • Use of a mechanical CPR device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98199, United States

Location

The Ottawa Hospital

Thunder Bay, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

  • Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.

    PMID: 21296838DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Interventions

Technology

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Limitations and Caveats

Open label study - providers not blinded to intervention. High rates of missing CPR process measures.

Results Point of Contact

Title
Susanne May, Ph.D.
Organization
Resusciatation Outcomes Consortium, University of Washington
sjmay@uw.edu
206-685-1302

Study Officials

  • Susanne May, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Judy Powell, BSN

    University of Washington

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

June 25, 2012

Results First Posted

June 25, 2012

Record last verified: 2012-05

Locations

US(2)CA(1)