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

Primary Purpose

Heart Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
Standard cardiopulmonary resuscitation (S-CPR)
Sponsored by
Advanced Circulatory Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest focused on measuring Heart Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation, Impedance Threshold Device, Active Compression Decompression, ResQPOD, ResQPump, Survival, Out-of-hospital, Prehospital, ResQCPR System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Exclusion Criteria: 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

Sites / Locations

  • Site 07: Indianapolis, IN
  • Site 06: Washtenaw & Livingston Counties, MI
  • Site 04: Oakland & Macomb Counties, MI
  • Site 02: Minneapolis, MN
  • Site 01: St. Paul, MN
  • Site 03: Whatcom County, WA
  • Site 05: Oshkosh, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Conventional standard cardiopulmonary resuscitation (S-CPR)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events
Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.
Return of Spontaneous Circulation (ROSC)
Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.
Survival to Hospital (e.g., Intensive Care Unit) Admission
Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.
Survival to 24 Hours
Number of patients who were alive 24 hours after the initial cardiac arrest.
Survival to Hospital Discharge
Survival to 90 Days
Number of patients who are known to be alive 90 days after the index cardiac arrest.
Survival to 365 Days
Number of patients who are alive 365 days after the index cardiac arrest.
Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]
CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores.

Full Information

First Posted
September 12, 2005
Last Updated
December 6, 2017
Sponsor
Advanced Circulatory Systems
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00189423
Brief Title
ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
Acronym
ResQ
Official Title
ResQ Trial: Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of funding. Follow-up completed for all enrolled subjects.
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Circulatory Systems
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Despite receiving conventional, standard CPR (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, nontraumatic cardiac arrest in adults in the United States is estimated to be less than 5%. Many factors contribute to the current 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 ACD and an 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 (nonfunctional or placebo) or active (functional) ITD. The results from the hemodynamic study demonstrated that systolic blood pressure, the primary end point, increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD (P less than 0.05). Intensive care unit admission rate was the primary end point of the clinical outcome study. Comparisons: The objective of this two-arm, multisite, randomized, pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR compared to ACD-CPR+ITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventional standard cardiopulmonary resuscitation (S-CPR)
Intervention Type
Device
Intervention Name(s)
Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
Other Intervention Name(s)
Impedance threshold device: ResQPOD CE CA, Device used to perform ACD-CPR: ResQPump
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard cardiopulmonary resuscitation (S-CPR)
Intervention Description
Conventional standard cardiopulmonary resuscitation (S-CPR)
Primary Outcome Measure Information:
Title
Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3
Description
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.
Time Frame
When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge
Secondary Outcome Measure Information:
Title
Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events
Description
Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.
Time Frame
Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge
Title
Return of Spontaneous Circulation (ROSC)
Description
Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.
Time Frame
Time of cardiac arrest until discontinuation of efforts
Title
Survival to Hospital (e.g., Intensive Care Unit) Admission
Description
Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.
Time Frame
Time of hospital admission, up to 1 day after cardiac arrest
Title
Survival to 24 Hours
Description
Number of patients who were alive 24 hours after the initial cardiac arrest.
Time Frame
24 hours following cardiac arrest
Title
Survival to Hospital Discharge
Time Frame
cardiac arrest to hospital discharge
Title
Survival to 90 Days
Description
Number of patients who are known to be alive 90 days after the index cardiac arrest.
Time Frame
90 days following cardiac arrest
Title
Survival to 365 Days
Description
Number of patients who are alive 365 days after the index cardiac arrest.
Time Frame
365 days following cardiac arrest
Title
Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]
Description
CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores.
Time Frame
One year after index arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith G. Lurie, MD
Organizational Affiliation
Advanced Circulatory Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 07: Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site 06: Washtenaw & Livingston Counties, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Site 04: Oakland & Macomb Counties, MI
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site 02: Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Site 01: St. Paul, MN
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Site 03: Whatcom County, WA
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Site 05: Oshkosh, WI
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14568898
Citation
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.
Results Reference
background
PubMed Identifier
9054757
Citation
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.
Results Reference
background
PubMed Identifier
15891326
Citation
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.
Results Reference
background
PubMed Identifier
15172704
Citation
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.
Results Reference
background
PubMed Identifier
11273935
Citation
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.
Results Reference
background
PubMed Identifier
10451462
Citation
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.
Results Reference
background
PubMed Identifier
8923582
Citation
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.
Results Reference
background
PubMed Identifier
8923583
Citation
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.
Results Reference
background
PubMed Identifier
10825624
Citation
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.
Results Reference
background
PubMed Identifier
10704165
Citation
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.
Results Reference
background
PubMed Identifier
10507710
Citation
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.
Results Reference
background
PubMed Identifier
15993724
Citation
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.
Results Reference
background
PubMed Identifier
15818098
Citation
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.
Results Reference
background
PubMed Identifier
11772887
Citation
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.
Results Reference
background
PubMed Identifier
11801347
Citation
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.
Results Reference
background
PubMed Identifier
15081185
Citation
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.
Results Reference
background
PubMed Identifier
12456407
Citation
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.
Results Reference
background
PubMed Identifier
15166836
Citation
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.
Results Reference
background
PubMed Identifier
8176802
Citation
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.
Results Reference
background
PubMed Identifier
11919340
Citation
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.
Results Reference
background
PubMed Identifier
21251705
Citation
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.
Results Reference
result
Links:
URL
http://www.advancedcirculatory.com
Description
Sponsor: Advanced Circulatory Systems, Inc. home page
URL
http://beaumonthospitals.com
Description
Site 04: Wm Beaumont Hospital home page

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

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