Hyperinvasive Approach in Cardiac Arrest

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Terminated

CT.gov ID

NCT01511666

Collaborator

(none)

256

Enrollment

Location

Arms

91.8

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.

Condition or Disease	Intervention/Treatment	Phase
Out-of Hospital Cardiac Arrest	Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS Other: Standard care	N/A

Detailed Description

Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.

Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, ECLS and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care.

Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.

Standard postresuscitation care will follow.

Study Design

Study Type:

Interventional

Actual Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. "Prague OHCA Study"

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Oct 25, 2020

Actual Study Completion Date :

Oct 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperinvasive arm Hyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.	Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS ECLS states for extracorporeal life support. Other Names: LUCAS Rhinochill ECLS
Active Comparator: Standard arm Patients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.	Other: Standard care Standard care as per recent guidelines will be provided.

Arm

Intervention/Treatment

Experimental: Hyperinvasive arm

Hyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.

Device: Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS

ECLS states for extracorporeal life support.

Other Names:

LUCAS

Rhinochill

ECLS

Active Comparator: Standard arm

Patients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.

Other: Standard care

Standard care as per recent guidelines will be provided.

Outcome Measures

Primary Outcome Measures

Composite endpoint of survival with good neurological outcome (CPC 1-2). [6 months]

Secondary Outcome Measures

Neurological recovery [30 days]
Neurological recovery will be defined as no or minimal neurological impairment (CPC 1 or 2) at any timepoint within first 30 days after initial cardiac arrest.
Cardiac recovery [30 days]
Cardiac recovery will be assessed by the clinical status of hemodynamic stability defined as no need for pharmacological or mechanical cardiac support. Systolic function will be measured by echocardiography .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

minimum of 18 and maximum of 65 years
witnessed out-of-hospital cardiac arrest of presumed cardiac cause
minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC
unconsciousness (Glasgow Coma Score < 8)
ECMO team and bed-capacity in cardiac center available.

Exclusion Criteria:

OHCA of presumed non-cardiac cause
unwitnessed collapse
pregnancy
sustained ROSC within 5 minutes of ACLS performed by EMS team
conscious patient
known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
suspected or confirmed acute stroke
known severe chronic organ dysfunction or other limitations in therapy
"do not resuscitate" order or other circumstances making 180 day survival unlikely
known pre-arrest cerebral performance category CPC ≥ 3.