Trial Outcomes & Findings for Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve (NCT NCT00394706)

Results Overview

The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

11738 participants

Primary outcome timeframe

Hospital discharge or death prior to discharge

Results posted on

2018-08-09

Participant Flow

Clinical sites enrolled patients during a run-in period with the first patient enrolled on June 7, 2007. The run-in period ranged from from 2 to 6 months across the sites. The last patient was enrolled in the evaluable phase on November 6, 2009. All patients were enrolled in the pre-hospital EMS setting.

Participant milestones

Participant milestones
Measure	Analyze Early + ITD Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.	Analyze Early + Sham Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Early, Not in ITD vs Sham Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Analyze Later + ITD Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Analyze Later + Sham Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Later, Not in ITD vs. Sham Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Not in AEvAL, ITD Device Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.	Not in AEvAL, Sham Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
Overall Study STARTED	1819	1862	1624	1633	1636	1384	929	851
Overall Study COMPLETED	1815	1860	1615	1632	1634	1377	926	851
Overall Study NOT COMPLETED	4	2	9	1	2	7	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Analyze Early + ITD Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.	Analyze Early + Sham Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Early, Not in ITD vs Sham Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Analyze Later + ITD Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Analyze Later + Sham Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Later, Not in ITD vs. Sham Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Not in AEvAL, ITD Device Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.	Not in AEvAL, Sham Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
Overall Study Withdrawal by Subject	2	0	1	0	0	2	1	0
Overall Study Lost to Follow-up	2	2	8	1	2	5	2	0

Baseline Characteristics

Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Analyze Early + ITD n=1817 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.	Analyze Early + Sham n=1861 Participants Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Early, Not in ITD vs Sham n=1621 Participants Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Analyze Later + ITD n=1631 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Analyze Later + Sham n=1633 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Later, Not in ITD vs. Sham n=1379 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Not in AEvAL, ITD Device n=929 Participants Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.	Not in AEvAL, Sham n=851 Participants Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.	Total n=11722 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	11 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	734 Participants n=5 Participants	809 Participants n=7 Participants	687 Participants n=5 Participants	693 Participants n=4 Participants	675 Participants n=21 Participants	590 Participants n=8 Participants	381 Participants n=8 Participants	370 Participants n=24 Participants	4939 Participants n=42 Participants
Age, Categorical >=65 years	1082 Participants n=5 Participants	1050 Participants n=7 Participants	932 Participants n=5 Participants	937 Participants n=4 Participants	954 Participants n=21 Participants	789 Participants n=8 Participants	547 Participants n=8 Participants	481 Participants n=24 Participants	6772 Participants n=42 Participants
Age, Continuous	67.3 years STANDARD_DEVIATION 16.3 • n=5 Participants	66.6 years STANDARD_DEVIATION 16.4 • n=7 Participants	66.3 years STANDARD_DEVIATION 17.0 • n=5 Participants	67.2 years STANDARD_DEVIATION 16.6 • n=4 Participants	67.1 years STANDARD_DEVIATION 16.4 • n=21 Participants	66.3 years STANDARD_DEVIATION 16.7 • n=8 Participants	67.7 years STANDARD_DEVIATION 16.3 • n=8 Participants	66.7 years STANDARD_DEVIATION 16.7 • n=24 Participants	66.9 years STANDARD_DEVIATION 16.6 • n=42 Participants
Sex: Female, Male Female	609 Participants n=5 Participants	673 Participants n=7 Participants	605 Participants n=5 Participants	615 Participants n=4 Participants	578 Participants n=21 Participants	486 Participants n=8 Participants	313 Participants n=8 Participants	303 Participants n=24 Participants	4182 Participants n=42 Participants
Sex: Female, Male Male	1208 Participants n=5 Participants	1188 Participants n=7 Participants	1016 Participants n=5 Participants	1016 Participants n=4 Participants	1055 Participants n=21 Participants	893 Participants n=8 Participants	616 Participants n=8 Participants	548 Participants n=24 Participants	7540 Participants n=42 Participants
Region of Enrollment United States	733 participants n=5 Participants	764 participants n=7 Participants	411 participants n=5 Participants	691 participants n=4 Participants	698 participants n=21 Participants	400 participants n=8 Participants	534 participants n=8 Participants	489 participants n=24 Participants	4720 participants n=42 Participants
Region of Enrollment Canada	1084 participants n=5 Participants	1097 participants n=7 Participants	1210 participants n=5 Participants	940 participants n=4 Participants	935 participants n=21 Participants	979 participants n=8 Participants	395 participants n=8 Participants	362 participants n=24 Participants	7002 participants n=42 Participants

PRIMARY outcome

Timeframe: Hospital discharge or death prior to discharge

Population: Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.

The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.

Outcome measures

Outcome measures
Measure	Analyze Early n=5290 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Analyze Later n=4643 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Active ITD n=4373 Participants Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Sham ITD n=4345 Participants Sham ITD used by EMS providers in the pre-hospital setting.
Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).	310 participants	273 participants	254 participants	260 participants

SECONDARY outcome

Timeframe: Survival to hospital discharge or death before discharge

Population: Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.

Outcome measures

Outcome measures
Measure	Analyze Early n=5290 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Analyze Later n=4643 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Active ITD n=4373 Participants Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Sham ITD n=4345 Participants Sham ITD used by EMS providers in the pre-hospital setting.
Survival to Hospital Discharge	427 participants	372 participants	357 participants	355 participants

SECONDARY outcome

Timeframe: 6 months post hospital discharge

Population: ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.

The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).

Outcome measures

Outcome measures
Measure	Analyze Early n=308 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Analyze Later n=274 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Active ITD n=218 Participants Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Sham ITD n=223 Participants Sham ITD used by EMS providers in the pre-hospital setting.
Modified Rankin Score at 6 Months After Hospital Discharge	1.7 units on a scale Standard Deviation 1.8	1.8 units on a scale Standard Deviation 1.8	1.8 units on a scale Standard Deviation 1.9	1.6 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 6 months post hospital discharge

Population: ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.

The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.

Outcome measures

Outcome measures
Measure	Analyze Early n=318 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Analyze Later n=265 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Active ITD n=214 Participants Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Sham ITD n=226 Participants Sham ITD used by EMS providers in the pre-hospital setting.
Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months	18.3 units on a scale Standard Deviation 6.0	18.5 units on a scale Standard Deviation 5.5	18.0 units on a scale Standard Deviation 6.3	18.7 units on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: 6 months post hospital discharge

Population: ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.

The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).

Outcome measures

Outcome measures
Measure	Analyze Early n=273 Participants Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Analyze Later n=240 Participants Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Active ITD n=191 Participants Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Sham ITD n=189 Participants Sham ITD used by EMS providers in the pre-hospital setting.
Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months	0.74 units on a scale Standard Deviation 0.34	0.73 units on a scale Standard Deviation 0.35	0.71 units on a scale Standard Deviation 0.36	0.75 units on a scale Standard Deviation 0.33

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Analyze Early + ITD n=2310 participants at risk Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.	Analyze Early + Sham n=2321 participants at risk Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Early, Not in ITD vs Sham n=2051 participants at risk Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Analyze Later + ITD n=2156 participants at risk Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.	Analyze Later + Sham n=2191 participants at risk Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.	Analyze Later, Not in ITD vs. Sham n=1839 participants at risk Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.	Not in AEvAL, ITD Device n=1336 participants at risk Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.	Not in AEvAL, Sham n=1278 participants at risk Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
Respiratory, thoracic and mediastinal disorders Airway bleeding	2.7% 62/2310 • Number of events 64	3.4% 79/2321 • Number of events 79	1.4% 28/2051 • Number of events 28	3.1% 67/2156 • Number of events 67	3.1% 67/2191 • Number of events 69	1.4% 26/1839 • Number of events 28	4.5% 60/1336 • Number of events 61	4.0% 51/1278 • Number of events 51
Respiratory, thoracic and mediastinal disorders Pulmonary edema	4.2% 98/2310 • Number of events 99	5.2% 120/2321 • Number of events 121	4.8% 98/2051 • Number of events 98	4.8% 104/2156 • Number of events 104	5.4% 118/2191 • Number of events 118	5.4% 99/1839 • Number of events 101	10.0% 134/1336 • Number of events 135	8.5% 108/1278 • Number of events 109
Skin and subcutaneous tissue disorders Defibrillator burns to chest	0.00% 0/2310	0.00% 0/2321	0.05% 1/2051 • Number of events 1	0.00% 0/2156	0.00% 0/2191	0.00% 0/1839	0.00% 0/1336	0.00% 0/1278
Hepatobiliary disorders Liver lacerations	0.00% 0/2310	0.00% 0/2321	0.00% 0/2051	0.00% 0/2156	0.00% 0/2191	0.00% 0/1839	0.00% 0/1336	0.08% 1/1278 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Siobhan Brown, PhD-Biostatistician

University of Washington

Phone: 206-685-1302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place