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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL077863-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Heart and Stroke Foundation of Canada | OTHER |
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The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the rate of survival to hospital discharge is not affected by use of continuous compressions with passive or positive pressure ventilation (intervention group) versus CPR with compressions interrupted for ventilation at a ratio of 30:2 (control group).
The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). For this study, CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation followed by rhythm analysis or until restoration of spontaneous circulation (ROSC), whichever occurs first. ICC consists of series of three cycles of standard CPR each cycle comprised of chest compressions with interposed ventilations at a compression:ventilation ratio of 30:2 (per AHA guidelines) followed by rhythm analysis or until ROSC, whichever occurs first. In either patient group, the duration of manual CPR before the first rhythm analysis will be 30 seconds or 120 seconds. This treatment period will be followed by two cycles of compressions then rhythm analysis (i.e. each of approximately 2 minutes duration) in either group. Other aims of the trial are to compare survival to discharge among patients grouped by first-recorded rhythm or other a priori subgroups, as well as to compare neurological status at discharge, mechanistic outcomes or adverse events between control and intervention groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard CPR | Active Comparator | American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations |
|
| Continuous chest compressions | Experimental | Continuous compression CPR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard CPR | Other | 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge | Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. | Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Scoring at or Below a 3 on the MRS Scale | Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myron Weisfeldt, MD, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Resuscitation Center | Birmingham | Alabama | 35294 | United States | ||
| The Pittsburgh Resuscitation Network, University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26550795 | Derived | Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators. Trial of Continuous or Interrupted Chest Compressions during CPR. N Engl J Med. 2015 Dec 3;373(23):2203-14. doi: 10.1056/NEJMoa1509139. Epub 2015 Nov 9. | |
| 25728722 |
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In this cluster randomized crossover trial, there are situations where age and gender are not known prior to the treatment being administered. These missing data account for the discrepancy between the enrollment number in the protocol section (23,711) and those in the participant flow module (23,687).
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard CPR | American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first. |
| FG001 | Continuous Chest Compressions | Continuous compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard CPR | American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge | Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. | The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). | Posted | Number | participants | Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. |
|
Adverse event data were collected from the time a participating agency arrived on scene and up to 24 hours after Emergency Department arrival
The following are commonly observed in patients who experience cardiac arrest or resuscitative efforts, and may or may not be attributable to specific resuscitation therapies. These were monitored and reported but not considered as adverse events of the study intervention. These include, but not limited to: pulmonary edema, airway bleeding, death, Clinical diagnoses of pneumonia, sepsis, cerebral bleeding, stroke, seizures, rearrest, serious rib fractures, and sternal fractures.
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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 | Standard CPR | American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Airway Bleed | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanne May | University of Washington, Resuscitation Outcomes Consortium | 206-685-1302 | rochelp@uwctc.org |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| American Heart Association |
| OTHER |
| Defence Research and Development Canada | INDUSTRY |
| U.S. Army Medical Research and Development Command | FED |
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|
| Continuous chest compressions | Other | Continuous chest compressions during the first 6 minutes of the resuscitation. |
|
| Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. |
| Pittsburgh |
| Pennsylvania |
| 15261 |
| 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 | Seattle | Washington | 98195-6422 | 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 | K1Y 4E9 | Canada |
| Rescu | Toronto | Ontario | M5B 1W8 | Canada |
| Brown SP, Wang H, Aufderheide TP, Vaillancourt C, Schmicker RH, Cheskes S, Straight R, Kudenchuk P, Morrison L, Colella MR, Condle J, Gamez G, Hostler D, Kayea T, Ragsdale S, Stephens S, Nichol G; ROC Investigators. A randomized trial of continuous versus interrupted chest compressions in out-of-hospital cardiac arrest: rationale for and design of the Resuscitation Outcomes Consortium Continuous Chest Compressions Trial. Am Heart J. 2015 Mar;169(3):334-341.e5. doi: 10.1016/j.ahj.2014.11.011. Epub 2014 Nov 20. |
| BG001 | Continuous Chest Compressions | Continuous compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Continuous Chest Compressions | Continuous compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation. |
|
|
| Secondary | Percentage of Participants Scoring at or Below a 3 on the MRS Scale | Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead | Posted | Number | percentage of participants | Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. |
|
|
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| 0 |
| 11,045 |
| 1,197 |
| 11,045 |
| EG001 | Continuous Chest Compressions | Continuous compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation. | 0 | 12,642 | 1,310 | 12,642 |
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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