Circulation Improving Resuscitation Care (CIRC)

Not Applicable

Completed

• Conditions: Cardiopulmonary Resuscitation; Cardiac Arrest
• Interventions: Other: Manual; Device: AutoPulse

• Registration Number: NCT00597207
• Lead Sponsor: Zoll Medical Corporation

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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Primary Completion: 2011-02
• Study Completion: 2013-12
• Results First Submitted: 2014-03-08
• Results First Submitted QC: 2014-03-08
• Results First Posted: 2014-04-14
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Manual	Manual CPR
1	AutoPulse	Mechanical CPR with AutoPulse

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Hillsborough Fire Rescue; 🇺🇸 Tampa, Florida, United States

Vienna EMS; 🇦🇹 Vienna, Austria

Gold Cross EMS; 🇺🇸 Menasha, Wisconsin, United States

Nijmegen EMS; 🇳🇱 Nijmegen, Netherlands

Houston Fire; 🇺🇸 Houston, Texas, United States