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International Device Assisted Controlled Sequential Elevation CPR Registry

ConditionCardiac Arrest, Out-Of-Hospital
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHennepin Healthcare Research Institute

About this trial

The purpose of this prospective observational cardiopulmonary resuscitation (CPR) registry is to track the use and clinical outcomes from emergency medical systems across the US and Europe that have implemented a system of care approach applied rapidly to cardiac arrest that includes using the combination of an impedance threshold device (ITD), and either manual active compression-decompression (ACD) CPR device or automated compression device, with a Head Up CPR device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is at least 18 years of age

Patient is in active cardiac arrest, as defined by presence of either ventricular fibrillation or ventricular tachycardia, or pulseless electrical activity, or asystole at time of enrollment.

Patient receives either a) active-compression decompression cardiopulmonary resuscitation b) automated suction-cup based CPR with an impedance threshold device (ITD) c) manual CPR with an ITD

Subject receives device assisted controlled elevation of the head and thorax.

Disqualifiers

None

Trial population

Patients with out-of-hospital cardiac arrest in areas where emergency medical services that have a Head Up CPR based system of care in their cardiac arrest protocol as part of routine clinical care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Head Up CPR based bundle of care

    Device

    All patients in this registry receive the intervention, a Head Up Cardiopulmonary Resuscitation (CPR) based bundle of care. This bundle of care includes the use of multiple FDA approved devices. The components of the Head Up CPR bundle are 1) a single or combination of CPR methods including manual, active-compression decompression CPR, or automated suction-cup based CPR 2) An impedance threshold device 3) An automated patient positioning device capable of elevating the head and thorax

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Head Up CPR based bundle of care1 intervention

Trial outcomes

Primary outcomes

1

Return of Spontaneous Circulation

Presence of cardiac activity with a perfusing blood pressure

Time frame
From the start of CPR to the presence of cardiac activity. The time period in which this outcome will varies and is estimated to range from 0 minutes up to around 40 minutes.
2

Survival

If the patient survived admission to the hospital until hospital discharge

Time frame
The time period in which this outcome will occur will vary, may extend up to 60 days.
3

Survival with Favorable Neurological Function

If the patient survived admission to the hospital until hospital discharge with favorable Cerebral Performance Category (CPC) Score as defined CPC 1 or 2.

Time frame
The time period in which this outcome will occur will vary, may extend up to 60 days.

Secondary outcomes

1

End tidal CO2 (ETCO2)

ETCO2 is an indirect measure of perfusion during CPR

Time frame
ETCO2 will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.
2

Cerebral Oximetry

Near-infrared spectroscopy (NIRS) capable of measuring regional tissue oxygenation.

Time frame
If the participating EMS system in the registry uses NIRS cerebral oximetry, it will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hennepin Healthcare Research Institute

Lead sponsor

Source ClinicalTrials.gov
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