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Clinical Trial: ResQ Trial: Impact of an Impedance Threshold Device and Active Compression Decompression CPR on Survival from Out-of-Hospital Cardiac Arrest
This study is not yet open for patient recruitment.
Verified by Advanced Circulatory Systems September 2005
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Purpose
| Condition | Intervention |
|---|---|
| Heart Arrest Death, Sudden, Cardiac Cardiopulmonary Resuscitation | Device: ResQPOD CE CA, an impedance threshold device (ITD) Device: ResQPump, an active compression decompression CPR device |
MedlinePlus related topics: End of Life Issues; Heart Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: ResQ Trial: Comparison of Standard Cardiopulmonary Resuscitation (CPR) Alone Versus Active Compression Decompression CPR Plus an Impedance Threshold Device (ITD) Versus Standard CPR Plus an ITD on Survival from Out-of-Hospital Cardiac Arrest
Secondary Outcomes: Rate of adverse events; Return of spontaneous circulation (ROSC); Survival to 1 hour; Survival to hospital (e.g. intensive care unit) admission; Survival to 24 hours; Survival to 30 days; Survival to 90 days; Survival to 365 days; Neurological recovery at hospital discharge, 30 days, 90 days and one year; as measured by: Cerebral Performance Category (CPC), Overall Performance Category (OPC) and Health Utilities Index Mark 3 (HUI3); Cognitive Abilities Screening Instrument (CASI),
Expected Total Enrollment: 2450
Study start: October 2005
Despite receiving conventional, standard cardiopulmonary resuscitation (S-CPR), most patients who experience out-of-hospital cardiac arrest die prior to arriving at a hospital. At the present time, the hospital discharge rate following out-of-hospital, non-traumatic cardiac arrest in adults in the United States is estimated to be <5%. Many factors contribute to the currently poor survival statistics, including the inefficiency of the technique itself. CPR provides only 10% to 20% of normal myocardial perfusion, and only 20% to 30% of physiologically normal cerebral perfusion.
A new method of CPR that combines active compression decompression (ACD-CPR) and an impedance threshold device (ITD) (ACD-CPR+ITD), has been shown in animal models and in clinical trials conducted in Europe to provide significantly more blood flow to the vital organs and to improve survival rates when compared to S-CPR or ACD-CPR alone.
ACD-CPR+ITD works by decreasing intrathoracic pressure during the chest wall recoil (or decompression) phase of CPR, creating a vacuum within the thorax relative to the rest of the body. When compared with controls, use of ACD-CPR+ITD: a) enhances blood return to the thorax during the chest wall recoil phase, b) enhances blood flow to the heart and brain, c) provides real-time feedback to rescuers to maintain high quality CPR, d) improves overall CPR efficiency and, as a result of the forgoing, e) improves short-term survival rates.
The sponsor and others recently evaluated the effectiveness of the combination of conventional, manual standard CPR±ITD in animals and humans. The ITD increased short-term survival rates in these studies as well. Two clinical trials were performed in Milwaukee, Wisconsin under IDE (#G980125). Both compared S-CPR with either a sham (non-functional or placebo) or active (functional) ITD. The results from the hemodynamic study demonstrated that systolic blood pressure, the primary endpoint, increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD (P<0.05). Intensive care unit admission rate was the primary endpoint of the clinical outcome study.
Comparisons: The objective of this 3-arm, multi-site, randomized, pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR, ACD-CPR+ITD, and S-CPR+ITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems.
Eligibility
Inclusion Criteria:
- Adult subjects initially presumed or known to be 18 years of age or older
- Subjects who present with out-of-hospital cardiac arrest from presumed cardiac etiology and who receive CPR by EMS personnel for at least one minute
- Subjects whose airways are managed with a cuffed ET tube, Combitube or laryngeal mask airway or facemask.
Exclusion Criteria
- Adult subjects presumed or known to be < 18 years of age
- Subjects with known or likely traumatic injuries causing cardiac arrest or cardiac arrest of presumed non-cardiac origin
- Subjects with pre-existing DNR orders
- Subjects with signs of obvious clinical death or conditions that preclude the use of CPR
- Family or legal representative request that the subject not be entered into the study
- Subjects experiencing in-hospital cardiac arrest
- Subjects with a recent sternotomy with wound not appearing completely healed (if unknown) or less than six months (if known)
- Subjects who received less than one minute of CPR by EMS personnel
- Subjects with a complete airway obstruction that cannot be cleared or in whom attempts at advanced airway management are unsuccessful
- Subjects intubated with a leaky or uncuffed advanced airway device or presence of stomas, tracheotomies or tracheostomies
- Subjects who re-arrest and are encountered by EMS within 365 days of the index cardiac arrest
Location and Contact Information
Michigan
William Beaumont Hospital, Royal Oak, Michigan, 48073, United States
Patrick Medado 248-898-0124 pmedado@beaumonthospitals.com
Robert A Swor, DO, Principal Investigator
Brian O''''Neil, MD, Sub-Investigator
Minnesota
Regions Hospital Emergency Medical Services, St. Paul, Minnesota, 55101, United States
Joshua G Salzman, MA 651-793-4002 joshua.g.salzman@healthpartners.com
Ralph J Frascone, MD, Principal Investigator
Hennepin County Emergency Medical Services, Minneapolis, Minnesota, 55415, United States
George Vasquez, EMT-P 612-873-6042 george.vasquez@co.hennepin.mn.us
Brian Mahoney, MD, Principal Investigator
Washington
Whatcom County Emergency Medical Services, Bellingham, Washington, 98225, United States
Janice Lapsansky 360-739-5776 janice@squelch.net
Marvin Wayne, MD, Principal Investigator
Wisconsin
Oshkosh Fire Department, Oshkosh, Wisconsin, 54901, United States
Kimberly Deja, RN 414-805-2573 kdeja@mcw.edu
Tom P Aufderheide, MD, Principal Investigator
Ronald G Pirrallo, MD, Sub-Investigator
Michelle Peters, MD, Sub-Investigator
Steven J Stroman, MD, Sub-Investigator
Keith G Lurie, MD, Principal Investigator, Advanced Circulatory Systems, Inc.
More Information
Medical College of Wisconsin - ResQ Trial home page
Publications
Wolcke BB, Mauer DK, Schoefmann MF, Teichmann H, Provo TA, Lindner KH, Dick WF, Aeppli D, Lurie KG. Comparison of standard cardiopulmonary resuscitation versus the combination of active compression-decompression cardiopulmonary resuscitation and an inspiratory impedance threshold device for out-of-hospital cardiac arrest. Circulation. 2003 Nov 4;108(18):2201-5. Epub 2003 Oct 20.
Plaisance P, Adnet F, Vicaut E, Hennequin B, Magne P, Prudhomme C, Lambert Y, Cantineau JP, Leopold C, Ferracci C, Gizzi M, Payen D. Benefit of active compression-decompression cardiopulmonary resuscitation as a prehospital advanced cardiac life support. A randomized multicenter study. Circulation. 1997 Feb 18;95(4):955-61.
Plaisance P, Soleil C, Lurie KG, Vicaut E, Ducros L, Payen D. Use of an inspiratory impedance threshold device on a facemask and endotracheal tube to reduce intrathoracic pressures during the decompression phase of active compression-decompression cardiopulmonary resuscitation. Crit Care Med. 2005 May;33(5):990-4.
Plaisance P, Lurie KG, Vicaut E, Martin D, Gueugniaud PY, Petit JL, Payen D. Evaluation of an impedance threshold device in patients receiving active compression-decompression cardiopulmonary resuscitation for out of hospital cardiac arrest. Resuscitation. 2004 Jun;61(3):265-71.
Voelckel WG, Lurie KG, Zielinski T, McKnite S, Plaisance P, Wenzel V, Lindner KH. The effects of positive end-expiratory pressure during active compression decompression cardiopulmonary resuscitation with the inspiratory threshold valve. Anesth Analg. 2001 Apr;92(4):967-74.
Plaisance P, Lurie KG, Vicaut E, Adnet F, Petit JL, Epain D, Ecollan P, Gruat R, Cavagna P, Biens J, Payen D. A comparison of standard cardiopulmonary resuscitation and active compression-decompression resuscitation for out-of-hospital cardiac arrest. French Active Compression-Decompression Cardiopulmonary Resuscitation Study Group. N Engl J Med. 1999 Aug 19;341(8):569-75.
Schneider T, Wik L, Baubin M, Dirks B, Ellinger K, Gisch T, Haghfelt T, Plaisance P, Vandemheen K. Active compression-decompression cardiopulmonary resuscitation--instructor and student manual for teaching and training. Part I: The workshop. Resuscitation. 1996 Oct;32(3):203-6.
Wik L, Schneider T, Baubin M, Dirks B, Ellinger K, Gisch T, Haghfelt T, Plaisance P, Vandemheen K. Active compression-decompression cardiopulmonary resuscitation--instructor and student manual for teaching and training. Part II: A student and instructor manual. Resuscitation. 1996 Oct;32(3):206-12. No abstract available.
Lurie K, Voelckel W, Plaisance P, Zielinski T, McKnite S, Kor D, Sugiyama A, Sukhum P. Use of an inspiratory impedance threshold valve during cardiopulmonary resuscitation: a progress report. Resuscitation. 2000 May;44(3):219-30. Review.
Plaisance P, Lurie KG, Payen D. Inspiratory impedance during active compression-decompression cardiopulmonary resuscitation: a randomized evaluation in patients in cardiac arrest. Circulation. 2000 Mar 7;101(9):989-94.
Mauer DK, Nolan J, Plaisance P, Sitter H, Benoit H, Stiell IG, Sofianos E, Keiding N, Lurie KG. Effect of active compression-decompression resuscitation (ACD-CPR) on survival: a combined analysis using individual patient data. Resuscitation. 1999 Aug;41(3):249-56.
Pirrallo RG, Aufderheide TP, Provo TA, Lurie KG. Effect of an inspiratory impedance threshold device on hemodynamics during conventional manual cardiopulmonary resuscitation. Resuscitation. 2005 Jul;66(1):13-20.
Aufderheide TP, Pirrallo RG, Provo TA, Lurie KG. Clinical evaluation of an inspiratory impedance threshold device during standard cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest. Crit Care Med. 2005 Apr;33(4):734-40.
Lurie KG, Zielinski T, McKnite S, Aufderheide T, Voelckel W. Use of an inspiratory impedance valve improves neurologically intact survival in a porcine model of ventricular fibrillation. Circulation. 2002 Jan 1;105(1):124-9.
Langhelle A, Stromme T, Sunde K, Wik L, Nicolaysen G, Steen PA. Inspiratory impedance threshold valve during CPR. Resuscitation. 2002 Jan;52(1):39-48.
Yannopoulos D, Sigurdsson G, McKnite S, Benditt D, Lurie KG. Reducing ventilation frequency combined with an inspiratory impedance device improves CPR efficiency in swine model of cardiac arrest. Resuscitation. 2004 Apr;61(1):75-82.
Raedler C, Voelckel WG, Wenzel V, Bahlmann L, Baumeier W, Schmittinger CA, Herff H, Krismer AC, Lindner KH, Lurie KG. Vasopressor response in a porcine model of hypothermic cardiac arrest is improved with active compression-decompression cardiopulmonary resuscitation using the inspiratory impedance threshold valve. Anesth Analg. 2002 Dec;95(6):1496-502, table of contents.
Frascone RJ, Bitz D, Lurie K. Combination of active compression decompression cardiopulmonary resuscitation and the inspiratory impedance threshold device: state of the art. Curr Opin Crit Care. 2004 Jun;10(3):193-201. Review.
Lurie KG, Shultz JJ, Callaham ML, Schwab TM, Gisch T, Rector T, Frascone RJ, Long L. Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest. JAMA. 1994 May 11;271(18):1405-11.
Voelckel WG, Lurie KG, Sweeney M, McKnite S, Zielinski T, Lindstrom P, Peterson C, Wenzel V, Lindner KH. Effects of active compression-decompression cardiopulmonary resuscitation with the inspiratory threshold valve in a young porcine model of cardiac arrest. Pediatr Res. 2002 Apr;51(4):523-7.
Last Updated: September 16, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00189423
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20
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