Trial Outcomes & Findings for Circulation Improving Resuscitation Care (CIRC) (NCT NCT00597207)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4231 participants

Primary outcome timeframe

From time of first contact until hospital discharge, up to 90 days.

Results posted on

2018-07-24

Participant milestones
Measure	iA-CPR 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	M-CPR 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
Overall Study STARTED	2099	2132
Overall Study COMPLETED	2094	2125
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal
Measure	iA-CPR 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	M-CPR 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
Overall Study Lost to Follow-up	5	7

Circulation Improving Resuscitation Care (CIRC)

Baseline characteristics by cohort
Measure	iA-CPR n=2099 Participants 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	M-CPR n=2132 Participants 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 n=4231 Participants Total of all reporting groups
Age, Customized 18-59 years	706 participants n=5 Participants	734 participants n=7 Participants	1440 participants n=5 Participants
Age, Customized 60-74 years	671 participants n=5 Participants	689 participants n=7 Participants	1360 participants n=5 Participants
Age, Customized 75+ years	722 participants n=5 Participants	709 participants n=7 Participants	1431 participants n=5 Participants
Sex: Female, Male Female	784 Participants n=5 Participants	837 Participants n=7 Participants	1621 Participants n=5 Participants
Sex: Female, Male Male	1315 Participants n=5 Participants	1295 Participants n=7 Participants	2610 Participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	iA-CPR n=2094 Participants 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	M-CPR n=2125 Participants 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
Hospital Discharge	196 participants	233 participants

Serious events: 11 serious events

Other events: 242 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 225 other events

Deaths: 0 deaths

Serious adverse events
Measure	iA-CPR n=2099 participants at risk 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	M-CPR n=2132 participants at risk 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
Injury, poisoning and procedural complications CPR related injuries	0.52% 11/2099 • Number of events 11	0.05% 1/2132 • Number of events 1

Other adverse events
Measure	iA-CPR n=2099 participants at risk 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	M-CPR n=2132 participants at risk 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
Injury, poisoning and procedural complications Pneumothorax	1.6% 33/2099 • Number of events 33	0.94% 20/2132 • Number of events 20
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.6% 159/2099 • Number of events 159	8.3% 176/2132 • Number of events 176
Injury, poisoning and procedural complications Rib Fractures	3.3% 69/2099 • Number of events 69	1.5% 31/2132 • Number of events 31
Injury, poisoning and procedural complications Subcutaneous emphysema	1.0% 21/2099 • Number of events 21	0.28% 6/2132 • Number of events 6

ZOLL Medical Corporation

Phone: 978-421-9655

Restriction type: LTE60