Heart ArrestResQNCT00189423
ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
A study testing Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) and Standard cardiopulmonary resuscitation (S-CPR) in people with Heart Arrest and Death, Sudden, Cardiac, run by Advanced Circulatory Systems at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation
- What is being tested?
- Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) and Standard cardiopulmonary resuscitation (S-CPR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,653 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2005to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Site 06: Washtenaw & Livingston Counties, MI
Ann Arbor, Michigan, 48106
Site 03: Whatcom County, WA
Bellingham, Washington, 98225
Site 07: Indianapolis, IN
Indianapolis, Indiana, 46202
Site 02: Minneapolis, MN
Minneapolis, Minnesota, 55415
Site 05: Oshkosh, WI
Oshkosh, Wisconsin, 54901
Site 04: Oakland & Macomb Counties, MI
Royal Oak, Michigan, 48073
Site 01: St. Paul, MN
Saint Paul, Minnesota, 55101
About this study
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
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.
Read the 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.
- Being tested
- Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR), Standard cardiopulmonary resuscitation (S-CPR)
- Keywords
- Heart Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation, Impedance Threshold Device, Active Compression Decompression, ResQPOD, ResQPump, Survival, Out-of-hospital, Prehospital, ResQCPR System
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)Device
Also called Impedance threshold device: ResQPOD CE CA, Device used to perform ACD-CPR: ResQPump
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.
Standard cardiopulmonary resuscitation (S-CPR)Procedure or surgery
Conventional standard cardiopulmonary resuscitation (S-CPR)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) Receives: 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) Receives: Procedure: Standard cardiopulmonary resuscitation (S-CPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge
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.
Measured: Time of cardiac arrest until discontinuation of efforts
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.
Measured: Time of hospital admission, up to 1 day after cardiac arrest
Survival to 24 Hours
Number of patients who were alive 24 hours after the initial cardiac arrest.
Measured: 24 hours following cardiac arrest
Survival to Hospital Discharge
Measured: cardiac arrest to hospital discharge
Survival to 90 Days
Number of patients who are known to be alive 90 days after the index cardiac arrest.
Measured: 90 days following cardiac arrest
Survival to 365 Days
Number of patients who are alive 365 days after the index cardiac arrest.
Measured: 365 days following 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.
Measured: One year after index arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Terminated due to lack of funding. Follow-up completed for all enrolled subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Circulatory Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Keith G. Lurie, MD, Principal investigator, Advanced Circulatory Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189423
- Sponsor's protocol ID
- 265
- Other IDs
- R44HL065851-03, 2R44HL065851-03, 43-0303-000
- Acronym
- ResQ
- Status last verified
- Dec 2017
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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. doi: 10.1161/01.CIR.0000095787.99180.B5. Epub 2003 Oct 20.
PubMed 14568898Plaisance 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.
PubMed 9054757Plaisance 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.
PubMed 15891326Plaisance 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.
PubMed 15172704Voelckel 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.
PubMed 11273935Plaisance 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.
PubMed 10451462Schneider 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.
PubMed 8923582Wik 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.
PubMed 8923583Lurie 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.
PubMed 10825624Plaisance 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.
PubMed 10704165Mauer 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.
PubMed 10507710Pirrallo 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.
PubMed 15993724Aufderheide 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.
PubMed 15818098Lurie 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.
PubMed 11772887Langhelle 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.
PubMed 11801347
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00189423
- Acronym / sponsor ID
- ResQ / 265
- Keywords
- Heart Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation, Impedance Threshold Device, Active Compression Decompression, ResQPOD, ResQPump, Survival
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of funding. Follow-up completed for all enrolled subjects.
- Enrolment
- 1,653 participants (actual)
- Lead sponsor
- Advanced Circulatory SystemsIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 22 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) |
| 2 | Active comparator | Procedure: Standard cardiopulmonary resuscitation (S-CPR)Conventional standard cardiopulmonary resuscitation (S-CPR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)Also: Impedance threshold device: ResQPOD CE CA, Device used to perform ACD-CPR: ResQPumpThe 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. | Device | 1 |
| Standard cardiopulmonary resuscitation (S-CPR)Conventional standard cardiopulmonary resuscitation (S-CPR) | Procedure or surgery | 2 |
Primary outcome
Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3
Time frame: When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge
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.
8 secondary outcomes
Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events
Time frame: Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge
Return of Spontaneous Circulation (ROSC)
Time frame: Time of cardiac arrest until discontinuation of efforts
Survival to Hospital (e.g., Intensive Care Unit) Admission
Time frame: Time of hospital admission, up to 1 day after cardiac arrest
Survival to 24 Hours
Time frame: 24 hours following cardiac arrest
Survival to Hospital Discharge
Time frame: cardiac arrest to hospital discharge
Survival to 90 Days
Time frame: 90 days following cardiac arrest
Survival to 365 Days
Time frame: 365 days following cardiac arrest
Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]
Time frame: One year after index arrest
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14568898Wolcke 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.
- Background: PubMed 9054757Plaisance 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.
- Background: PubMed 15891326Plaisance 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.
- Background: PubMed 15172704Plaisance 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.
- Background: PubMed 11273935Voelckel 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.
- Background: PubMed 10451462Plaisance 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.
- Background: PubMed 8923582Schneider 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.
- Background: PubMed 8923583Wik 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.
- Background: PubMed 10825624Lurie 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.
- Background: PubMed 10704165Plaisance 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.
- Background: PubMed 10507710Mauer 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.
- Background: PubMed 15993724Pirrallo 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.
- Sponsor: Advanced Circulatory Systems, Inc. home pageLink provided by the sponsor.
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Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith G. Lurie, MD principal investigator
Advanced Circulatory Systems
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) and Standard cardiopulmonary resuscitation (S-CPR) in people with Heart Arrest and Death, Sudden, Cardiac, run by Advanced Circulatory Systems at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 (time frame: When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189423, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.