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

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ClinicalTrials.gov Identifier: NCT00189423
Recruitment Status : Terminated (Terminated due to lack of funding. Follow-up completed for all enrolled subjects.)
First Posted : September 19, 2005
Results First Posted : August 22, 2012
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Advanced Circulatory Systems

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Heart Arrest
Death, Sudden, Cardiac
Cardiopulmonary Resuscitation
Cardiac Arrest
Interventions Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
Procedure: Standard cardiopulmonary resuscitation (S-CPR)
Enrollment 1653
Recruitment Details The study was conducted under a waiver of informed consent for emergency research that was approved by the U.S. Food and Drug Administration and by the Institutional Review Boards at participating study sites. All adults with out-of-hospital cardiac arrest were eligible for the study.
Pre-assignment Details All sites were required to complete a run-in phase prior to to beginning randomization. A total of 2667 patients (197 run-in, 2470 pivotal) were provisionally enrolled and received randomized CPR treatment. Of these, 1653 pivotal patients met the final selection criteria (non-traumatic arrest due to cardiac cause).
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description Conventional standard cardiopulmonary resuscitation (S-CPR) Active compression decompression CPR plus an Impedance Threshold Device
Period Title: Overall Study
Started 813 840
Completed 48 74
Not Completed 765 766
Reason Not Completed
Death             746             747
Withdrawal by Subject             9             9
Lost to Follow-up             10             10
Arm/Group Title Standard CPR ACD CPR Plus ITD Total
Hide Arm/Group Description Conventional standard cardiopulmonary resuscitation (S-CPR) Active compression decompression CPR plus an Impedance Threshold Device Total of all reporting groups
Overall Number of Baseline Participants 813 840 1653
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 813 participants 840 participants 1653 participants
<=18 years
0
   0.0%
1
   0.1%
1
   0.1%
Between 18 and 65 years
377
  46.4%
369
  43.9%
746
  45.1%
>=65 years
436
  53.6%
470
  56.0%
906
  54.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 813 participants 840 participants 1653 participants
66.8  (14.5) 67.0  (15.2) 66.9  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 813 participants 840 participants 1653 participants
Female
274
  33.7%
282
  33.6%
556
  33.6%
Male
539
  66.3%
558
  66.4%
1097
  66.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 813 participants 840 participants 1653 participants
813 840 1653
1.Primary Outcome
Title Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
47 75
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard CPR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
1.07 to 2.36
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
766 787
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard CPR, ACD CPR Plus ITD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin of 5%
Statistical Test of Hypothesis P-Value 0.0001
Comments p value is for non-inferiority with a margin of 5% (exact binomial test)
Method Fisher Exact test, for non-inferiority
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard CPR, ACD CPR Plus ITD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Return of Spontaneous Circulation (ROSC)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
324 343
4.Secondary Outcome
Title Survival to Hospital (e.g., Intensive Care Unit) Admission
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
216 237
5.Secondary Outcome
Title Survival to 24 Hours
Hide Description Number of patients who were alive 24 hours after the initial cardiac arrest.
Time Frame 24 hours following cardiac arrest
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
176 197
6.Secondary Outcome
Title Survival to Hospital Discharge
Hide Description [Not Specified]
Time Frame cardiac arrest to hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
104 80
7.Secondary Outcome
Title Survival to 90 Days
Hide Description Number of patients who are known to be alive 90 days after the index cardiac arrest.
Time Frame 90 days following cardiac arrest
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
58 87
8.Secondary Outcome
Title Survival to 365 Days
Hide Description Number of patients who are alive 365 days after the index cardiac arrest.
Time Frame 365 days following cardiac arrest
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 813 840
Measure Type: Number
Unit of Measure: patients
48 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard CPR, ACD CPR Plus ITD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description:
Conventional standard cardiopulmonary resuscitation (S-CPR)
Active compression decompression CPR plus an Impedance Threshold Device
Overall Number of Participants Analyzed 41 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
93.7  (11.8) 94.7  (4.4)
Time Frame Through hospital discharge, up to 30 days after index arrest.
Adverse Event Reporting Description Only serious adverse events were assessed for this study.
 
Arm/Group Title Standard CPR ACD CPR Plus ITD
Hide Arm/Group Description Conventional standard cardiopulmonary resuscitation (S-CPR) Active compression decompression CPR plus an Impedance Threshold Device
All-Cause Mortality
Standard CPR ACD CPR Plus ITD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard CPR ACD CPR Plus ITD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   766/813 (94.22%)      787/840 (93.69%)    
General disorders     
death   729/813 (89.67%)  729 734/840 (87.38%)  734
re-arrest   161/813 (19.80%)  161 184/840 (21.90%)  184
seizure   13/813 (1.60%)  13 11/840 (1.31%)  11
bleeding requiring intervention   3/813 (0.37%)  3 7/840 (0.83%)  7
cerebral bleeding   3/813 (0.37%)  3 2/840 (0.24%)  2
internal organ injury   0/813 (0.00%)  0 1/840 (0.12%)  1
Respiratory, thoracic and mediastinal disorders     
pulmonary edema   62/813 (7.63%)  62 93/840 (11.07%)  93
rib/sterna fracture   14/813 (1.72%)  14 11/840 (1.31%)  11
pneumothorax   7/813 (0.86%)  7 10/840 (1.19%)  10
hemothorax   1/813 (0.12%)  1 2/840 (0.24%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard CPR ACD CPR Plus ITD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Trials
Organization: Advanced Circulatory Systems, Inc.
Phone: 651-403-5600
Other Publications:
Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT00189423     History of Changes
Obsolete Identifiers: NCT00225953
Other Study ID Numbers: 265
R44HL065851-03 ( U.S. NIH Grant/Contract )
2R44HL065851-03 ( U.S. NIH Grant/Contract )
43-0303-000
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: March 1, 2012
Results First Posted: August 22, 2012
Last Update Posted: December 8, 2017