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| ID | Type | Description | Link |
|---|---|---|---|
| HL077863 |
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Terminated because preliminary data suggested no difference in the strategies.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.
The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.
Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Use of Impedance Threshold Device (ITD) |
|
| 2 | Sham Comparator | 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impedance Threshold Device (ITD) | Device | Use of Impedance Threshold Device (ITD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to Hospital Discharge | Survival to hospital discharge or death before discharge | |
| Modified Rankin Score at 6 Months After Hospital Discharge | The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). |
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Inclusion Criteria:
Exclusion Criteria:
Common:
For Analyzing Late versus Early
For ITD:
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| Name | Affiliation | Role |
|---|---|---|
| Myron L Weisfeldt, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Resuscitation Center | Birmingham | Alabama | 35294 | United States | ||
| UCSD-San Diego Resuscitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21879897 | Background | 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. | |
| 21879896 |
| Label | URL |
|---|---|
| Click here for more information about the ROC PRIMED Trial | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Defence Research and Development Canada | INDUSTRY |
| Heart and Stroke Foundation of Canada | OTHER |
| American Heart Association | OTHER |
Not provided
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| Sham ITD |
| Device |
Sham ITD |
|
| Analyze early | Other | 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. |
|
| Analyze later | Other | 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. |
|
| 6 months post hospital discharge |
| Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months | The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse. | 6 months post hospital discharge |
| Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months | The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0). | 6 months post hospital discharge |
| San Diego |
| California |
| 92103 |
| United States |
| Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University | Portland | Oregon | 97239 | United States |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Seattle-King County Center for Resuscitation Research, University of Washington | Seattle | Washington | 98195 | United States |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research | Ottawa | Ontario | K1Y4E9 | Canada |
| Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto | Toronto | Ontario | M5B1W8 | Canada |
| Result |
| 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. |
| 29310869 | Derived | 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. |
| 29055890 | Derived | 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. |
| 27760796 | Derived | 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. |
| 27554946 | Derived | 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. |
| 25565457 | Derived | 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. |
| 25252721 | Derived | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Gender missing for one ITD and one analyze earlier subject. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes. | Posted | Number | participants | Hospital discharge or death prior to discharge |
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| Secondary | Survival to Hospital Discharge | Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes. | Posted | Number | participants | Survival to hospital discharge or death before discharge |
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| Secondary | Modified Rankin Score at 6 Months After Hospital Discharge | The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). | ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment. | Posted | Mean | Standard Deviation | units on a scale | 6 months post hospital discharge |
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| Secondary | Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months | The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse. | ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment. | Posted | Mean | Standard Deviation | units on a scale | 6 months post hospital discharge |
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| Secondary | Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months | The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0). | ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment. | Posted | Mean | Standard Deviation | units on a scale | 6 months post hospital discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 154 | 2,310 | 0 | 2,310 | ||
| EG001 | 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. | 193 | 2,321 | 0 | 2,321 | ||
| EG002 | 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. | 122 | 2,051 | 0 | 2,051 | ||
| EG003 | 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. | 166 | 2,156 | 0 | 2,156 | ||
| EG004 | 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. | 174 | 2,191 | 0 | 2,191 | ||
| EG005 | 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. | 121 | 1,839 | 0 | 1,839 | ||
| EG006 | 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. | 181 | 1,336 | 0 | 1,336 | ||
| EG007 | 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. | 152 | 1,278 | 0 | 1,278 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Airway bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Finding of frank blood or bloody fluids in the airway secretions, the oro- or naso-pharynx region, or the advanced airway by EMS or ED/hospital personnel. |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Defibrillator burns to chest | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Liver lacerations | Hepatobiliary disorders | Non-systematic Assessment | Liver lacerations secondary to CPR with bleeding and hypotension. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siobhan Brown, PhD-Biostatistician | University of Washington | 206-685-1302 | spes@uw.edu |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Canada |
|
| Comparison of the rates of MRS <=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring. | t-test, 2 sided | 0.71 | To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990) | Risk Difference (RD) | -0.1 | 2-Sided | 95 | -1.1 | 0.8 | Estimate of the rate of MRS <= 3 in the active ITD arm minus the rate in the Sham ITD arm. | Superiority or Other |
| OG003 |
| Sham ITD |
Sham ITD used by EMS providers in the pre-hospital setting. |
|
|
|
| OG003 | Sham ITD | Sham ITD used by EMS providers in the pre-hospital setting. |
|
|
|
| OG003 | Sham ITD | Sham ITD used by EMS providers in the pre-hospital setting. |
|
|
|
| OG002 | Active ITD | Use of Impedance Threshold Device by EMS providers in the pre-hospital setting. |
| OG003 | Sham ITD | Sham ITD used by EMS providers in the pre-hospital setting. |
|
|
|