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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01325870
Recruitment Status : Completed
First Posted : March 30, 2011
Results First Posted : July 17, 2014
Last Update Posted : August 12, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Advanced Circulatory Systems

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Sudden Cardiac Death Device: ACD-CPR Device: ITPR Procedure: S-CPR Device: Impedance Threshold Device (ITD) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ACD-CPR +ITD
Active Compression Decompression CPR with the ResQPRO device and ResQPOD ITD device.
Device: ACD-CPR
Other Name: ResQPRO Active Compression Decompression CPR Device (Advanced Circulatory Systems, Inc., Roseville, MN)

Device: Impedance Threshold Device (ITD)
Other Name: ResQPOD 16 (Advanced Circulatory Systems, Inc)

Experimental: S-CPR + ITPR Device: ITPR
standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
Other Name: CirQlator Intrathoracic Pressure Regulator (Advanced Circulatory Systems, Inc., Roseville, MN)

Active Comparator: S-CPR Procedure: S-CPR
standard manual CPR

Primary Outcome Measures :
  1. Mean Systolic and Diastolic Blood Pressures [ Time Frame: during CPR (day 1) ]
  2. 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

Secondary Outcome Measures :
  1. Mean Intrathoracic Pressure (Airway Pressure) [ Time Frame: during CPR (day 1) ]
    Intrathoracic pressures are reported relative to atmospheric pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01325870

United States, Michigan
Michigan State University- Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
Sponsors and Collaborators
Advanced Circulatory Systems
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Keith Lurie, MD Advanced Circulatory Systems


Responsible Party: Advanced Circulatory Systems Identifier: NCT01325870     History of Changes
Other Study ID Numbers: 43-0566-000
2R44HL082088 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2011    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: August 12, 2016
Last Verified: July 2016

Keywords provided by Advanced Circulatory Systems:
cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden