NCT00394706

Brief Summary

The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
11,738

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach
2 countries

9 active sites

Status
terminated

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

October 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 18, 2012

Completed
Last Updated

August 9, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

October 30, 2006

Results QC Date

March 23, 2012

Last Update Submit

July 12, 2018

Conditions

Heart Arrest

Keywords

cardiac arrestcardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

  • Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).

    The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.

    Hospital discharge or death prior to discharge

Secondary Outcomes (4)

  • Survival to Hospital Discharge

    Survival to hospital discharge or death before discharge

  • Modified Rankin Score at 6 Months After Hospital Discharge

    6 months post hospital discharge

  • Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months

    6 months post hospital discharge

  • Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months

    6 months post hospital discharge

Study Arms (4)

1

EXPERIMENTAL

Use of Impedance Threshold Device (ITD)

Device: Impedance Threshold Device (ITD)

2

SHAM COMPARATOR

Sham ITD

Device: Sham ITD

3

OTHER

Analyze early. Upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Other: Analyze early

4

OTHER

Analyze late. Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Other: Analyze later

Interventions

Impedance Threshold Device (ITD)DEVICE

Use of Impedance Threshold Device (ITD)

1
Sham ITDDEVICE

Sham ITD

2
Analyze earlyOTHER

Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.

3
Analyze laterOTHER

Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

4

Eligibility Criteria

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

You may not qualify if:

  • Common:
  • Do not attempt resuscitation (DNAR) orders
  • Blunt, penetrating, or burn-related injury
  • Patients with exsanguinations
  • Known prisoners
  • Known pregnancy
  • Non-ROC EMS agency/provider
  • For Analyzing Late versus Early
  • EMS-witnessed arrests
  • For ITD:
  • Tracheostomy present
  • CPR performed with the mechanical compression "Autopulse" device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alabama Resuscitation Center

Birmingham, Alabama, 35294, United States

Location

UCSD-San Diego Resuscitation Center

San Diego, California, 92103, United States

Location

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Seattle-King County Center for Resuscitation Research, University of Washington

Seattle, Washington, 98195, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research

Ottawa, Ontario, K1Y4E9, Canada

Location

Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (8)

  • Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.

    PMID: 21879897BACKGROUND

  • Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya MR, Wang HE, Morrison LJ, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M; ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):787-97. doi: 10.1056/NEJMoa1010076.

    PMID: 21879896RESULT

  • Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.

    PMID: 29310869DERIVED

  • Ho ML, Gatien M, Vaillancourt C, Whitham V, Stiell IG. Utility of prehospital electrocardiogram characteristics as prognostic markers in out-of-hospital pulseless electrical activity arrests. Emerg Med J. 2018 Feb;35(2):89-95. doi: 10.1136/emermed-2017-206878. Epub 2017 Oct 21.

    PMID: 29055890DERIVED

  • Reynolds JC, Grunau BE, Rittenberger JC, Sawyer KN, Kurz MC, Callaway CW. Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation. 2016 Dec 20;134(25):2084-2094. doi: 10.1161/CIRCULATIONAHA.116.023309. Epub 2016 Oct 19.

    PMID: 27760796DERIVED

  • Zheng R, Luo S, Liao J, Liu Z, Xu J, Zhan H, Liao X, Xiong Y, Idris A. Conversion to shockable rhythms is associated with better outcomes in out-of-hospital cardiac arrest patients with initial asystole but not in those with pulseless electrical activity. Resuscitation. 2016 Oct;107:88-93. doi: 10.1016/j.resuscitation.2016.08.008. Epub 2016 Aug 21.

    PMID: 27554946DERIVED

  • Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.

    PMID: 25565457DERIVED

  • Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.

    PMID: 25252721DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Siobhan Brown, PhD-Biostatistician
Organization
University of Washington
spes@uw.edu
206-685-1302

Study Officials

  • Myron L Weisfeldt, MD

    Johns Hopkins University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2006

First Posted

November 1, 2006

Study Start

June 1, 2007

Primary Completion

November 1, 2009

Study Completion

July 1, 2010

Last Updated

August 9, 2018

Results First Posted

April 18, 2012

Record last verified: 2018-07

Locations

US(7)CA(2)