Trial Outcomes & Findings for Continuous Chest Compressions vs AHA Standard CPR of 30:2 (NCT NCT01372748)
NCT ID: NCT01372748
Last Updated: 2016-12-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23711 participants
Primary outcome timeframe
Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
Results posted on
2016-12-28
Participant Flow
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).
Participant milestones
| Measure |
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.
|
Continuous Chest Compressions
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
|---|---|---|
|
Overall Study
STARTED
|
11045
|
12642
|
|
Overall Study
COMPLETED
|
11022
|
12603
|
|
Overall Study
NOT COMPLETED
|
23
|
39
|
Reasons for withdrawal
| Measure |
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.
|
Continuous Chest Compressions
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
34
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
Baseline Characteristics
Continuous Chest Compressions vs AHA Standard CPR of 30:2
Baseline characteristics by cohort
| Measure |
Standard CPR
n=11045 Participants
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.
|
Continuous Chest Compressions
n=12642 Participants
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
Total
n=23687 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Gender
Female
|
3926 Participants
n=5 Participants
|
4618 Participants
n=7 Participants
|
8544 Participants
n=5 Participants
|
|
Gender
Male
|
7119 Participants
n=5 Participants
|
8024 Participants
n=7 Participants
|
15143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
123 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1246 Participants
n=5 Participants
|
1350 Participants
n=7 Participants
|
2596 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1795 Participants
n=5 Participants
|
1931 Participants
n=7 Participants
|
3726 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7841 Participants
n=5 Participants
|
9180 Participants
n=7 Participants
|
17021 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6711 participants
n=5 Participants
|
8010 participants
n=7 Participants
|
14721 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4334 participants
n=5 Participants
|
4632 participants
n=7 Participants
|
8966 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.Population: 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).
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.
Outcome measures
| Measure |
Standard CPR
n=11022 Participants
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.
|
Continuous Chest Compressions
n=12603 Participants
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
|---|---|---|
|
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
|
1072 participants
|
1127 participants
|
SECONDARY outcome
Timeframe: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.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
Outcome measures
| Measure |
Standard CPR
n=10892 Participants
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.
|
Continuous Chest Compressions
n=12550 Participants
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
|---|---|---|
|
Percentage of Participants Scoring at or Below a 3 on the MRS Scale
|
7.7 percentage of participants
|
7.0 percentage of participants
|
Adverse Events
Standard CPR
Serious events: 0 serious events
Other events: 1197 other events
Deaths: 0 deaths
Continuous Chest Compressions
Serious events: 0 serious events
Other events: 1310 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard CPR
n=11045 participants at risk
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.
|
Continuous Chest Compressions
n=12642 participants at risk
Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Airway Bleed
|
6.9%
764/11045 • 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.
|
7.0%
881/12642 • 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.
|
|
Gastrointestinal disorders
Emesis
|
10.8%
1197/11045 • 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.
|
10.4%
1310/12642 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
9.7%
1072/11045 • 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.
|
9.0%
1137/12642 • 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.
|
Additional Information
Dr. Susanne May
University of Washington, Resuscitation Outcomes Consortium
Phone: 206-685-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60