Circulation Improving Resuscitation Care (CIRC)

• Sponsor: Zoll Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00597207
• Collaborator: Ullevaal University Hospital (Other)
• Enrollment: 4,231
• Locations: 5
• Arms: 2
• Duration (Months): 71
• Patients Per Site: 846.2
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest compression device Autopulse will improve survival compared to manual compressions.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest; Cardiopulmonary Resuscitation	Device: AutoPulse; Other: Manual	N/A

Detailed Description

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Several studies document sub optimal quality of manual chest compressions and this may influence outcome. However, studies comparing manual and mechanical chest compressions have resulted in conflicted results. The investigators think this may be based on methodology and design issues of the trials as much as not focusing on training and experience in operating a mechanical device clinically. Therefore the investigators will focus on these issues and implement three phases in the study (In field training, Run In phase, and Study phase). The investigators will also focus on early use of mechanical CPR after arrival at patient side and randomization at arrival. In order to achieve this the investigators will follow the Norwegian CPR Guidelines with 3 min CPR before defibrillation and the 3 min algorithm. Quality of CPR will be monitored.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4231 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Mechanical CPR with AutoPulse	Device: AutoPulse; Mechanical device that provides chest compression
Other: 2 Manual CPR	Other: Manual; Manual chest compression

Outcome Measures

Primary Outcome Measures

1. Hospital Discharge [From time of first contact until hospital discharge, up to 90 days.]

   Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patents aged 18 years (or local age of consent) or more who suffer non-traumatic arrest of presumed cardiac etiology in an out-of-hospital setting and who do not meet any of the exclusion criteria below.

Exclusion Criteria:

• Traumatic arrest (blunt, penetrating, burns)

• Arrest due to exsanguinations, strangulation, smoke inhalation, drug overdose, electrocution, hanging, drowning.

• Known or clinically apparent pregnancy

• Do Not Attempt to Resuscitate (DNAR) orders

• Apparent patient weight more than 225 kg (500 lbs)

• Wards of the state

• Prisoner

• CPR device other than AutoPulse

• Patients who are reached after 16 minutes after the time of emergency call (911). This exclusion is determined at the time of CRF abstraction, not during treatment of the patient.

• If patient is unaccompanied, or accompanied by a person or persons unfamiliar with their his-tory, determination of these exclusion criteria will, perforce, be left to the best estimation of the rescue personnel. At no time, should an attempt to determine these criteria be allowed to delay the administration of life-saving treatment.

• These criteria will be determined in the best estimation of the rescue personnel, or if the AutoPulse signals that the patient is outside the parameters for AutoPulse deployment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillsborough Fire Rescue	Tampa	Florida	United States	33610
2	Houston Fire	Houston	Texas	United States	77002
3	Gold Cross EMS	Menasha	Wisconsin	United States	54952
4	Vienna EMS	Vienna		Austria
5	Nijmegen EMS	Nijmegen		Netherlands

Sponsors and Collaborators

• Zoll Medical Corporation
• Ullevaal University Hospital

Investigators

• Principal Investigator: Lars Wik, MD, Ullevaal University Hospital
• Principal Investigator: David Persse, MD, Houston Fire

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zoll Medical Corporation
• ClinicalTrials.gov Identifier: NCT00597207
• Other Study ID Numbers: Zoll-0100
• First Posted: Jan 17, 2008
• Last Update Posted: Jul 24, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Zoll Medical Corporation: CPR; mechanical; manual; outcome; survival; quality
• Additional relevant MeSH terms: Heart Arrest

Study Results

Participant Flow

Arm/Group Title	iA-CPR	M-CPR
Arm/Group Description	Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions. AutoPulse: Mechanical device that provides chest compression	Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions. Manual: Manual chest compression
Period Title: Overall Study
STARTED	2099	2132
COMPLETED	2094	2125
NOT COMPLETED	5	7

Baseline Characteristics

Arm/Group Title	iA-CPR	M-CPR	Total
Arm/Group Description	Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions. AutoPulse: Mechanical device that provides chest compression	Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions. Manual: Manual chest compression	Total of all reporting groups
Overall Participants	2099	2132	4231
Age, Customized (participants) [Number]
18-59 years	706 33.6%	734 34.4%	1440 34%
60-74 years	671 32%	689 32.3%	1360 32.1%
75+ years	722 34.4%	709 33.3%	1431 33.8%
Sex: Female, Male (Count of Participants)
Female	784 37.4%	837 39.3%	1621 38.3%
Male	1315 62.6%	1295 60.7%	2610 61.7%

Outcome Measures

1. Primary Outcome

Title	Hospital Discharge
Description	Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.
Time Frame	From time of first contact until hospital discharge, up to 90 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iA-CPR	M-CPR
Arm/Group Description	Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions. AutoPulse: Mechanical device that provides chest compression	Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions. Manual: Manual chest compression
Measure Participants	2094	2125
Number [participants]	196 9.3%	233 10.9%

Adverse Events

Arm/Group Title	iA-CPR		M-CPR
Arm/Group Description	Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions. AutoPulse: Mechanical device that provides chest compression		Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions. Manual: Manual chest compression
All Cause Mortality
	iA-CPR		M-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	iA-CPR		M-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/2099 (0.5%)		1/2132 (0%)
Injury, poisoning and procedural complications
CPR related injuries	11/2099 (0.5%)	11	1/2132 (0%)	1
Other (Not Including Serious) Adverse Events
	iA-CPR		M-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	242/2099 (11.5%)		225/2132 (10.6%)
Injury, poisoning and procedural complications
Pneumothorax	33/2099 (1.6%)	33	20/2132 (0.9%)	20
Rib Fractures	69/2099 (3.3%)	69	31/2132 (1.5%)	31
Subcutaneous emphysema	21/2099 (1%)	21	6/2132 (0.3%)	6
Respiratory, thoracic and mediastinal disorders
Pulmonary edema	159/2099 (7.6%)	159	176/2132 (8.3%)	176

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.