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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT01325870
First received: March 28, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention
Cardiac Arrest
Sudden Cardiac Death
Device: ACD-CPR
Device: ITPR
Procedure: S-CPR
Device: Impedance Threshold Device (ITD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:
  • Mean Systolic and Diastolic Blood Pressures [ Time Frame: during CPR (day 1) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR


Secondary Outcome Measures:
  • Mean Intrathoracic Pressure (Airway Pressure) [ Time Frame: during CPR (day 1) ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325870

Locations
United States, Michigan
Michigan State University- Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
Sponsors and Collaborators
Advanced Circulatory Systems
Investigators
Principal Investigator: Keith Lurie, MD Advanced Circulatory Systems
  More Information

Publications:

Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01325870     History of Changes
Other Study ID Numbers: 43-0566-000, 2R44HL082088
Study First Received: March 28, 2011
Results First Received: June 18, 2014
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Advanced Circulatory Systems:
cardiopulmonary resuscitation

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

ClinicalTrials.gov processed this record on September 16, 2014