Michigan State University- Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008, United States
NCT Number: NCT01325870
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kalamazoo, Michigan, 49008, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Initial Inclusion Criteria:
Final Inclusion Criteria:
Initial Exclusion Criteria:
Final Exclusion Criteria:
Other names: ResQPRO Active Compression Decompression CPR Device (Advanced Circulatory Systems, Inc., Roseville, MN)
standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
Other names: CirQlator Intrathoracic Pressure Regulator (Advanced Circulatory Systems, Inc., Roseville, MN)
standard manual CPR
Other names: ResQPOD 16 (Advanced Circulatory Systems, Inc)
Time frame: during CPR (day 1)
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
Time frame: during CPR (day 1)
Intrathoracic pressures are reported relative to atmospheric pressure
Advanced Circulatory Systems
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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