Circulation Improving Resuscitation Care (CIRC)

Cardiac Arrest Clinical Trial

— CIRC  

Official title:

A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597207
• Other study ID #: Zoll-0100
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2018
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4231
• Est. completion date: December 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Resuscitation
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• AutoPulse
Mechanical device that provides chest compression

Other:
• Manual
Manual chest compression

Locations

Country	Name	City	State
Austria	Vienna EMS	Vienna
Netherlands	Nijmegen EMS	Nijmegen
United States	Houston Fire	Houston	Texas
United States	Gold Cross EMS	Menasha	Wisconsin
United States	Hillsborough Fire Rescue	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Zoll Medical Corporation	Ullevaal University Hospital

Countries where clinical trial is conducted

United States,  Austria,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Discharge	Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.	From time of first contact until hospital discharge, up to 90 days.