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Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve

This study has been terminated.
(Terminated because preliminary data suggested no difference in the strategies.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394706
First Posted: November 1, 2006
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Defence Research and Development Canada
Heart and Stroke Foundation of Canada
American Heart Association
Information provided by (Responsible Party):
Susanne May, University of Washington
Results First Submitted: March 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Heart Arrest
Interventions: Device: Impedance Threshold Device (ITD)
Device: Sham ITD
Other: Analyze early
Other: Analyze later

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Clinical sites enrolled patients during a run-in period with the first patient enrolled on June 7, 2007. The run-in period ranged from from 2 to 6 months across the sites. The last patient was enrolled in the evaluable phase on November 6, 2009. All patients were enrolled in the pre-hospital EMS setting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Analyze Early + ITD 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. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
Analyze Early + Sham Analyze early: upon EMS 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 may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
Analyze Early, Not in ITD vs Sham Analyze early. Upon EMS 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 may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
Analyze Later + ITD Analyze later: 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. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
Analyze Later + Sham Analyze later: 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. Use of a sham ITD by EMS providers in the pre-hospital setting.
Analyze Later, Not in ITD vs. Sham Analyze later: 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. Neither an ITD nor sham device used.
Not in AEvAL, ITD Device Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
Not in AEvAL, Sham Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.

Participant Flow:   Overall Study
    Analyze Early + ITD   Analyze Early + Sham   Analyze Early, Not in ITD vs Sham   Analyze Later + ITD   Analyze Later + Sham   Analyze Later, Not in ITD vs. Sham   Not in AEvAL, ITD Device   Not in AEvAL, Sham
STARTED   1819   1862   1624   1633   1636   1384   929   851 
COMPLETED   1815   1860   1615   1632   1634   1377   926   851 
NOT COMPLETED   4   2   9   1   2   7   3   0 
Withdrawal by Subject                2                0                1                0                0                2                1                0 
Lost to Follow-up                2                2                8                1                2                5                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Analyze Early + ITD 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. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
Analyze Early + Sham Analyze early: upon EMS 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 may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
Analyze Early, Not in ITD vs Sham Analyze early. Upon EMS 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 may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
Analyze Later + ITD Analyze later: 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. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
Analyze Later + Sham Analyze later: 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. Use of a sham ITD by EMS providers in the pre-hospital setting.
Analyze Later, Not in ITD vs. Sham Analyze later: 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. Neither an ITD nor sham device used.
Not in AEvAL, ITD Device Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
Not in AEvAL, Sham Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
Total Total of all reporting groups

Baseline Measures
   Analyze Early + ITD   Analyze Early + Sham   Analyze Early, Not in ITD vs Sham   Analyze Later + ITD   Analyze Later + Sham   Analyze Later, Not in ITD vs. Sham   Not in AEvAL, ITD Device   Not in AEvAL, Sham   Total 
Overall Participants Analyzed 
[Units: Participants]
 1817   1861   1621   1631   1633   1379   929   851   11722 
Age [1] 
[Units: Participants]
                 
<=18 years   1   2   2   1   4   0   1   0   11 
Between 18 and 65 years   734   809   687   693   675   590   381   370   4939 
>=65 years   1082   1050   932   937   954   789   547   481   6772 
[1] Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 67.3  (16.3)   66.6  (16.4)   66.3  (17.0)   67.2  (16.6)   67.1  (16.4)   66.3  (16.7)   67.7  (16.3)   66.7  (16.7)   66.9  (16.6) 
[1] Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects.
Gender [1] 
[Units: Participants]
                 
Female   609   673   605   615   578   486   313   303   4182 
Male   1208   1188   1016   1016   1055   893   616   548   7540 
[1] Gender missing for one ITD and one analyze earlier subject.
Region of Enrollment 
[Units: Participants]
                 
United States   733   764   411   691   698   400   534   489   4720 
Canada   1084   1097   1210   940   935   979   395   362   7002 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).   [ Time Frame: Hospital discharge or death prior to discharge ]

2.  Secondary:   Survival to Hospital Discharge   [ Time Frame: Survival to hospital discharge or death before discharge ]

3.  Secondary:   Modified Rankin Score at 6 Months After Hospital Discharge   [ Time Frame: 6 months post hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months   [ Time Frame: 6 months post hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months   [ Time Frame: 6 months post hospital discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Siobhan Brown, PhD-Biostatistician
Organization: University of Washington
phone: 206-685-1302
e-mail: spes@uw.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Susanne May, University of Washington
ClinicalTrials.gov Identifier: NCT00394706     History of Changes
Other Study ID Numbers: 29919-A
HL077863
First Submitted: October 30, 2006
First Posted: November 1, 2006
Results First Submitted: March 23, 2012
Results First Posted: April 18, 2012
Last Update Posted: April 30, 2012