Hemodynamic Effects of Standard Cardiopulmonary Resuscitation (CPR), Active Compression Decompression CPR With an Inspiratory Impedance Device, and Standard CPR With an Intrathoracic Pressure Regulator During Out-of-hospital Cardiac Arrest

July 12, 2016 updated by: Advanced Circulatory Systems

Comparison of Standard Cardiopulmonary Resuscitation Alone Versus Active Compression Decompression Cardiopulmonary Resuscitation Plus an Impedance Threshold Device Versus Standard Cardiopulmonary Resuscitation Plus an Intrathoracic Pressure Regulator on Arterial Blood Pressures During Out-of-Hospital Cardiac Arrest

More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall survival rates averaging less than 5%. Low survival rates persist, in part, because manual chest compressions and ventilation, termed standard cardiopulmonary resuscitation (S-CPR), is an inherently inefficient process, providing less than 25% of normal blood flow to the heart and the brain. Hemodynamics are often compromised further by poor S-CPR techniques, especially inadequate chest compression and incomplete chest recoil. Active Compression Decompression CPR (ACD-CPR) is performed with a hand-held device that is attached to the patient's chest, and also includes a handle containing a metronome and force gauge to guide proper compression rate, depth and complete chest wall recoil. The impedance threshold device (ITD) is designed for rapid connection to an airway adjunct (e.g. facemask or endotracheal tube) and allows for positive pressure ventilation, while also impeding passive inspiratory gas exchange during chest wall decompression. Prior studies have shown that the combination of ACD-CPR + ITD enhances refilling of the heart after each compression by augmenting negative intrathoracic pressure during the decompression phase of CPR, resulting in improved cardiac and cerebral perfusion. The intrathoracic pressure regulator (ITPR) is a next generation inspiratory impedance therapy. The ITPR uses a regulated external vacuum source to lower the negative intrathoracic pressure and is therefore less dependent on the quality of CPR (e.g., completeness of chest wall recoil). The ITPR generates a pre-set continuous and controlled expiratory phase negative intrathoracic pressure that is interrupted only when positive pressure ventilation is needed to maintain oxygenation and provide gas exchange.

The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR, ACD- CPR + ITD, and S-CPR + ITPR in patients with out-of-hospital cardiac arrest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Michigan State University- Kalamazoo Center for Medical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Initial Inclusion Criteria:

  • Subject is initially presumed or known to be 18 years of age or older;
  • Subject presents with presumed non-traumatic, out-of-hospital cardiac arrest AND is a candidate for resuscitation attempt. [NOTE: the cardiac arrest may be witnessed OR unwitnessed];
  • Subject has a secured cuffed advanced airway [e.g., endotracheal tube, Combitube, King airway].

Final Inclusion Criteria:

  • Subject in whom femoral arterial access was successfully established;
  • Subject remained in cardiac arrest (undergoing CPR) at the time of hemodynamic data acquisition;
  • Subject in whom at least 5 minutes of continuous hemodynamic data were able to be collected, OR if ROSC occurs before 5 minutes, at least 2 minutes of hemodynamic data were able to be collected.

Initial Exclusion Criteria:

  • Subject has known pre-existing DNR orders in place prior to this cardiac arrest;
  • Subject has signs of obvious clinical death or conditions that preclude the use of CPR;
  • Subject's family or legal guardians request that the subject not be entered in the study at the time of arrest;
  • Subject has recent sternotomy, with wound not appearing completely healed (if date of sternotomy is unknown) or less than six months (if date of sternotomy is known);
  • Subject has a stoma, tracheotomy, or tracheostomy prior to arrest;
  • Subject is known or suspected to be pregnant;
  • Subject is known/suspected to be a prisoner.

Final Exclusion Criteria:

  • Subject in whom < 2 minutes of hemodynamic data were acquired while receiving CPR;
  • Subject in whom an arterial pressure catheter was not placed or arterial pressure was not able to be successfully monitored;
  • Subject is subsequently found to have had a traumatic arrest;
  • Subject was in asystole at time of initial arrest AND remained in asystole during resuscitation effort AND arrest was unwitnessed or unknown if witnessed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACD-CPR +ITD
Active Compression Decompression CPR with the ResQPRO device and ResQPOD ITD device.
Device: ACD-CPR
Other Names:
  • ResQPRO Active Compression Decompression CPR Device (Advanced Circulatory Systems, Inc., Roseville, MN)
Device: Impedance Threshold Device (ITD)
Other Names:
  • ResQPOD 16 (Advanced Circulatory Systems, Inc)
Experimental: S-CPR + ITPR
Device: ITPR
standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
Other Names:
  • CirQlator Intrathoracic Pressure Regulator (Advanced Circulatory Systems, Inc., Roseville, MN)
Active Comparator: S-CPR
Procedure: S-CPR
standard manual CPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Systolic and Diastolic Blood Pressures
Time Frame: during CPR (day 1)
during CPR (day 1)
Serious Adverse Events
Time Frame: during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up
Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR
during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Intrathoracic Pressure (Airway Pressure)
Time Frame: during CPR (day 1)
Intrathoracic pressures are reported relative to atmospheric pressure
during CPR (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Circulatory Systems

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Keith Lurie, MD, Advanced Circulatory Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43-0566-000
  • 2R44HL082088 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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