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

Cardiac Arrest Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00189423
• Other study ID #: 265
• Secondary ID: R44HL065851-032R
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 6, 2017
• Start date: October 2005
• Est. completion date: July 2010

Study information

• Verified date: December 2017
• Source: Advanced Circulatory Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 following out-of-hospital cardiac arrest.

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.

Other known NCT identifiers

• NCT00225953

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1653
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Resuscitation
• Death, Sudden
• Death, Sudden, Cardiac
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Procedure:
• Standard cardiopulmonary resuscitation (S-CPR)
Conventional standard cardiopulmonary resuscitation (S-CPR)

Locations

Country	Name	City	State
United States	Site 06: Washtenaw & Livingston Counties, MI	Ann Arbor	Michigan
United States	Site 03: Whatcom County, WA	Bellingham	Washington
United States	Site 07: Indianapolis, IN	Indianapolis	Indiana
United States	Site 02: Minneapolis, MN	Minneapolis	Minnesota
United States	Site 05: Oshkosh, WI	Oshkosh	Wisconsin
United States	Site 04: Oakland & Macomb Counties, MI	Royal Oak	Michigan
United States	Site 01: St. Paul, MN	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Circulatory Systems	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (21)

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 augmentat — View 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. — View 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. Review. — View Citation

Langhelle A, Strømme T, Sunde K, Wik L, Nicolaysen G, Steen PA. Inspiratory impedance threshold valve during CPR. Resuscitation. 2002 Jan;52(1):39-48. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Plaisance P, Adnet F, Vicaut E, Hennequin B, Magne P, Prudhomme C, Lambert Y, Cantineau JP, Léopold 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2003 Oct 20. — View 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge
Secondary	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.	Time of cardiac arrest until discontinuation of efforts
Secondary	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.	Time of hospital admission, up to 1 day after cardiac arrest
Secondary	Survival to 24 Hours	Number of patients who were alive 24 hours after the initial cardiac arrest.	24 hours following cardiac arrest
Secondary	Survival to Hospital Discharge		cardiac arrest to hospital discharge
Secondary	Survival to 90 Days	Number of patients who are known to be alive 90 days after the index cardiac arrest.	90 days following cardiac arrest
Secondary	Survival to 365 Days	Number of patients who are alive 365 days after the index cardiac arrest.	365 days following cardiac arrest
Secondary	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.	One year after index arrest

External Links

•   Site 01: Regions Hospital EMS home page
•   Site 02: Hennepin Co. EMS home page
•   Site 04: Wm Beaumont Hospital home page
•   Sponsor: Advanced Circulatory Systems, Inc. home page