Trial Outcomes & Findings for ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest (NCT NCT00189423)

NCT ID: NCT00189423

Last Updated: 2017-12-08

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1653 participants
• Primary outcome timeframe: When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge
• Results posted on: 2017-12-08

Participant Flow

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.

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).

Participant milestones

Measure	Standard CPR Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD Active compression decompression CPR plus an Impedance Threshold Device
Overall Study STARTED	813	840
Overall Study COMPLETED	48	74
Overall Study NOT COMPLETED	765	766

Reasons for withdrawal

Measure	Standard CPR Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD Active compression decompression CPR plus an Impedance Threshold Device
Overall Study Death	746	747
Overall Study Withdrawal by Subject	9	9
Overall Study Lost to Follow-up	10	10

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device	Total n=1653 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	377 Participants n=5 Participants	369 Participants n=7 Participants	746 Participants n=5 Participants
Age, Categorical >=65 years	436 Participants n=5 Participants	470 Participants n=7 Participants	906 Participants n=5 Participants
Age, Continuous	66.8 years STANDARD_DEVIATION 14.5 • n=5 Participants	67.0 years STANDARD_DEVIATION 15.2 • n=7 Participants	66.9 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	274 Participants n=5 Participants	282 Participants n=7 Participants	556 Participants n=5 Participants
Sex: Female, Male Male	539 Participants n=5 Participants	558 Participants n=7 Participants	1097 Participants n=5 Participants
Region of Enrollment United States	813 participants n=5 Participants	840 participants n=7 Participants	1653 participants n=5 Participants

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3	47 patients	75 patients

SECONDARY outcome

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

Population: Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.

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.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events	766 patients	787 patients

SECONDARY outcome

Timeframe: Time of cardiac arrest until discontinuation of efforts

Population: Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.

Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Return of Spontaneous Circulation (ROSC)	324 patients	343 patients

SECONDARY outcome

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

Population: 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.

Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Survival to Hospital (e.g., Intensive Care Unit) Admission	216 patients	237 patients

SECONDARY outcome

Timeframe: 24 hours following cardiac arrest

Population: Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.

Number of patients who were alive 24 hours after the initial cardiac arrest.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Survival to 24 Hours	176 patients	197 patients

SECONDARY outcome

Timeframe: cardiac arrest to hospital discharge

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Survival to Hospital Discharge	104 patients	80 patients

SECONDARY outcome

Timeframe: 90 days following cardiac arrest

Population: Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.

Number of patients who are known to be alive 90 days after the index cardiac arrest.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Survival to 90 Days	58 patients	87 patients

SECONDARY outcome

Timeframe: 365 days following cardiac arrest

Population: Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.

Number of patients who are alive 365 days after the index cardiac arrest.

Outcome measures

Measure	Standard CPR n=813 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 Participants Active compression decompression CPR plus an Impedance Threshold Device
Survival to 365 Days	48 patients	74 patients

SECONDARY outcome

Timeframe: One year after index arrest

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.

Outcome measures

Measure	Standard CPR n=41 Participants Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=30 Participants Active compression decompression CPR plus an Impedance Threshold Device
Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]	93.7 units on a scale Standard Deviation 11.8	94.7 units on a scale Standard Deviation 4.4

Adverse Events

Standard CPR

Serious events: 766 serious events

Other events: 0 other events

Deaths: 0 deaths

ACD CPR Plus ITD

Serious events: 787 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard CPR n=813 participants at risk Conventional standard cardiopulmonary resuscitation (S-CPR)	ACD CPR Plus ITD n=840 participants at risk Active compression decompression CPR plus an Impedance Threshold Device
General disorders death	89.7% 729/813 • Number of events 729 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	87.4% 734/840 • Number of events 734 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
General disorders re-arrest	19.8% 161/813 • Number of events 161 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	21.9% 184/840 • Number of events 184 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
Respiratory, thoracic and mediastinal disorders pulmonary edema	7.6% 62/813 • Number of events 62 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	11.1% 93/840 • Number of events 93 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
General disorders seizure	1.6% 13/813 • Number of events 13 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	1.3% 11/840 • Number of events 11 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
General disorders bleeding requiring intervention	0.37% 3/813 • Number of events 3 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	0.83% 7/840 • Number of events 7 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
Respiratory, thoracic and mediastinal disorders rib/sterna fracture	1.7% 14/813 • Number of events 14 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	1.3% 11/840 • Number of events 11 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
General disorders cerebral bleeding	0.37% 3/813 • Number of events 3 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	0.24% 2/840 • Number of events 2 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
General disorders internal organ injury	0.00% 0/813 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	0.12% 1/840 • Number of events 1 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.86% 7/813 • Number of events 7 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	1.2% 10/840 • Number of events 10 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.
Respiratory, thoracic and mediastinal disorders hemothorax	0.12% 1/813 • Number of events 1 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.	0.24% 2/840 • Number of events 2 • Through hospital discharge, up to 30 days after index arrest. Only serious adverse events were assessed for this study.

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Advanced Circulatory Systems, Inc.

Phone: 651-403-5600

Email: csetum@advancedcirculatory.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60