ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest

NCT00189423 | Terminated Results DMC

• 4 other identifiers: 265R44HL065851-032R44HL065851-0343-0303-000
• Study Type: interventional
• Target: 1,653
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic recovery and survival to hospital discharge following out-of-hospital cardiac arrest.

Conditions

Heart Arrest; Death, Sudden, Cardiac; Cardiopulmonary Resuscitation; Cardiac Arrest

Keywords

Heart Arrest; Cardiac Arrest; Cardiopulmonary Resuscitation; Impedance Threshold Device; Active Compression Decompression; ResQPOD; ResQPump; Survival; Out-of-hospital; Prehospital; ResQCPR System

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3

  favorable neurologic function is defined as modified Rankin Scale (MRS) score \<= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention.

  When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge

Secondary Outcomes (8)

• Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events

  Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge

• Return of Spontaneous Circulation (ROSC)

  Time of cardiac arrest until discontinuation of efforts

• Survival to Hospital (e.g., Intensive Care Unit) Admission

  Time of hospital admission, up to 1 day after cardiac arrest

• Survival to 24 Hours

  24 hours following cardiac arrest

• Survival to Hospital Discharge

  cardiac arrest to hospital discharge

Study Arms (2)

1

EXPERIMENTAL

Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD)

Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)

2

ACTIVE COMPARATOR

Conventional standard cardiopulmonary resuscitation (S-CPR)

Procedure: Standard cardiopulmonary resuscitation (S-CPR)

Interventions

Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) DEVICE

The ITD selectively prevents the influx of unnecessary respiratory gases into the patient during the chest wall recoil phase of CPR. The ResQPump, a hand-held device containing a suction cup, attaches to the chest and actively compresses and actively re-expands the chest during the performance of CPR.

Also known as: Impedance threshold device: ResQPOD CE CA, Device used to perform ACD-CPR: ResQPump

1

Standard cardiopulmonary resuscitation (S-CPR) PROCEDURE

Conventional standard cardiopulmonary resuscitation (S-CPR)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Emergency Medical Services (EMS) personnel for at least 1 minute
• Subjects whose airways are managed with a cuffed ET tube, combitube, or laryngeal mask airway or facemask

You may not qualify if:

• Adult subjects presumed or known to be less than 18 years of age
• Subjects with known or likely traumatic injuries causing cardiac arrest or cardiac arrest of presumed noncardiac origin
• Subjects with preexisting Do Not Resuscitate (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 6 months (if known)
• Subjects who received less than 1 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 rearrest and are encountered by EMS within 365 days of the index cardiac arrest

Sponsors & Collaborators

• Advanced Circulatory Systems: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

Site 07: Indianapolis, IN

Indianapolis, Indiana, 46202, United States

Location

Site 06: Washtenaw & Livingston Counties, MI

Ann Arbor, Michigan, 48106, United States

Location

Site 04: Oakland & Macomb Counties, MI

Royal Oak, Michigan, 48073, United States

Location

Site 02: Minneapolis, MN

Minneapolis, Minnesota, 55415, United States

Location

Site 01: St. Paul, MN

Saint Paul, Minnesota, 55101, United States

Location

Site 03: Whatcom County, WA

Bellingham, Washington, 98225, United States

Location

Site 05: Oshkosh, WI

Oshkosh, Wisconsin, 54901, United States

Location

Related Publications (21)

• 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. doi: 10.1161/01.CIR.0000095787.99180.B5. Epub 2003 Oct 20.

  PMID: 14568898 BACKGROUND

• 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. doi: 10.1161/01.cir.95.4.955.

  PMID: 9054757 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000163235.18990.f6.

  PMID: 15891326 BACKGROUND

• 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. doi: 10.1016/j.resuscitation.2004.01.032.

  PMID: 15172704 BACKGROUND

• 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. doi: 10.1097/00000539-200104000-00032.

  PMID: 11273935 BACKGROUND

• 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. doi: 10.1056/NEJM199908193410804.

  PMID: 10451462 BACKGROUND

• 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. doi: 10.1016/0300-9572(96)00946-x.

  PMID: 8923582 BACKGROUND

• 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. doi: 10.1016/0300-9572(96)82051-x. No abstract available.

  PMID: 8923583 BACKGROUND

• 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. doi: 10.1016/s0300-9572(00)00160-x.

  PMID: 10825624 BACKGROUND

• 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. doi: 10.1161/01.cir.101.9.989.

  PMID: 10704165 BACKGROUND

• 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. doi: 10.1016/s0300-9572(99)00073-8.

  PMID: 10507710 BACKGROUND

• 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. doi: 10.1016/j.resuscitation.2004.12.027.

  PMID: 15993724 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000155909.09061.12.

  PMID: 15818098 BACKGROUND

• 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. doi: 10.1161/hc0102.101391.

  PMID: 11772887 BACKGROUND

• 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. doi: 10.1016/s0300-9572(01)00442-7.

  PMID: 11801347 BACKGROUND

• 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. doi: 10.1016/j.resuscitation.2003.12.006.

  PMID: 15081185 BACKGROUND

• 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. doi: 10.1097/00000539-200212000-00007.

  PMID: 12456407 BACKGROUND

• 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. doi: 10.1097/01.ccx.0000126089.40242.a9.

  PMID: 15166836 BACKGROUND

• 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.

  PMID: 8176802 BACKGROUND

• 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. doi: 10.1203/00006450-200204000-00020.

  PMID: 11919340 BACKGROUND

• Aufderheide TP, Frascone RJ, Wayne MA, Mahoney BD, Swor RA, Domeier RM, Olinger ML, Holcomb RG, Tupper DE, Yannopoulos D, Lurie KG. Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial. Lancet. 2011 Jan 22;377(9762):301-11. doi: 10.1016/S0140-6736(10)62103-4.

  PMID: 21251705 RESULT

Related Links

• Sponsor: Advanced Circulatory Systems, Inc. home page

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Advanced Circulatory Systems, Inc.

csetum@advancedcirculatory.com

651-403-5600

Study Officials

• Keith G. Lurie, MD

  Advanced Circulatory Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 8, 2017
• Results First Posted: August 22, 2012

Record last verified: 2017-12

Locations

US (7)