CCC: Continuous Chest Compressions vs AHA Standard CPR of 30:2

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01372748
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Canadian Institutes of Health Research (CIHR) (Other), Heart and Stroke Foundation of Canada (Other), American Heart Association (Other), Defence Research and Development Canada (Industry), U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 23,711
• Locations: 7
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 3387.3
• Patients Per Site Per Month: 63.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest	Other: Standard CPR; Other: Continuous chest compressions	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23711 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard CPR American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations	Other: 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.
Experimental: Continuous chest compressions Continuous compression CPR	Other: Continuous chest compressions; Continuous chest compressions during the first 6 minutes of the resuscitation.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge [Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.]

   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.

Secondary Outcome Measures

1. Percentage of Participants Scoring at or Below a 3 on the MRS Scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or more (or local age of consent);

• Initial fire/Emergency Medical Services (EMS) chest compressions provided by Resuscitation Outcomes Consortium (ROC) study participating agency dispatched to the scene;

• Lack of the exclusion criteria below

Exclusion Criteria:

• EMS witnessed arrest;

• Written do not attempt resuscitation (DNAR) orders;

• Obvious primary asphyxia or respiratory cause of arrest (drowning, strangulation, hanging)

• Advanced airway placed prior to ROC EMS arrival, or pre-existing tracheostomy

• Traumatic cause (blunt, penetrating, burn) of arrest;

• Known prisoners;

• Known pregnancy;

• Uncontrolled bleeding or exsanguination

• Mechanical compression device used during study-assigned compression cycles

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Resuscitation Center	Birmingham	Alabama	United States	35294
2	The Pittsburgh Resuscitation Network, University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
3	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
4	Seattle-King County Center for Resuscitation Research	Seattle	Washington	United States	98195-6422
5	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
6	University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research	Ottawa	Ontario	Canada	K1Y 4E9
7	Rescu	Toronto	Ontario	Canada	M5B 1W8

Sponsors and Collaborators

• University of Washington
• National Heart, Lung, and Blood Institute (NHLBI)
• Canadian Institutes of Health Research (CIHR)
• Heart and Stroke Foundation of Canada
• American Heart Association
• Defence Research and Development Canada
• U.S. Army Medical Research and Development Command

Investigators

• Study Chair: Myron Weisfeldt, MD, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susanne May, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT01372748
• Other Study ID Numbers: 40404-B; 5U01HL077863-07
• First Posted: Jun 14, 2011
• Last Update Posted: Dec 28, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Susanne May, Principal Investigator, University of Washington: cardiac arrest; cardiopulmonary resuscitation
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Pre-assignment Detail	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).

Arm/Group Title	Standard CPR	Continuous Chest Compressions
Arm/Group Description	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 compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
Period Title: Overall Study
STARTED	11045	12642
COMPLETED	11022	12603
NOT COMPLETED	23	39

Baseline Characteristics

Arm/Group Title	Standard CPR	Continuous Chest Compressions	Total
Arm/Group Description	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 compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.	Total of all reporting groups
Overall Participants	11045	12642	23687
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.2 (17.0)	66.4 (17.2)	66.3 (17.1)
Gender (Count of Participants)
Female	3926 35.5%	4618 36.5%	8544 36.1%
Male	7119 64.5%	8024 63.5%	15143 63.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	14 0.1%	12 0.1%	26 0.1%
Asian	123 1.1%	140 1.1%	263 1.1%
Native Hawaiian or Other Pacific Islander	23 0.2%	28 0.2%	51 0.2%
Black or African American	1246 11.3%	1350 10.7%	2596 11%
White	1795 16.3%	1931 15.3%	3726 15.7%
More than one race	3 0%	1 0%	4 0%
Unknown or Not Reported	7841 71%	9180 72.6%	17021 71.9%
Region of Enrollment (participants) [Number]
Canada	6711 60.8%	8010 63.4%	14721 62.1%
United States	4334 39.2%	4632 36.6%	8966 37.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Description	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.
Time Frame	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Standard CPR	Continuous Chest Compressions
Arm/Group Description	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 compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
Measure Participants	11022	12603
Number [participants]	1072 9.7%	1127 8.9%

2. Secondary Outcome

Title	Percentage of Participants Scoring at or Below a 3 on the MRS Scale
Description	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
Time Frame	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard CPR	Continuous Chest Compressions
Arm/Group Description	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 compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
Measure Participants	10892	12550
Number [percentage of participants]	7.7 0.1%	7.0 0.1%

Adverse Events

Time Frame	Adverse event data were collected from the time a participating agency arrived on scene and up to 24 hours after Emergency Department arrival
Adverse Event Reporting Description	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.
Arm/Group Title	Standard CPR		Continuous Chest Compressions
Arm/Group Description	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 compression CPR Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.
All Cause Mortality
	Standard CPR		Continuous Chest Compressions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard CPR		Continuous Chest Compressions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11045 (0%)		0/12642 (0%)
Other (Not Including Serious) Adverse Events
	Standard CPR		Continuous Chest Compressions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1197/11045 (10.8%)		1310/12642 (10.4%)
Gastrointestinal disorders
Emesis	1197/11045 (10.8%)		1310/12642 (10.4%)
Respiratory, thoracic and mediastinal disorders
Airway Bleed	764/11045 (6.9%)		881/12642 (7%)
Pulmonary Edema	1072/11045 (9.7%)		1137/12642 (9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.