Heart ArrestPhase 3NCT00394706
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
A Phase 3 study testing Impedance Threshold Device (ITD), Analyze early and Analyze later in people with Heart Arrest, run by University of Washington at 9 sites in 2 countries.
Trial summary
The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Impedance Threshold Device (ITD), Analyze early and Analyze later
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,738 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jun 2007to Jul 2010
- Phase
- Phase 3
- 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
- All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.
Who cannot join
- Common:
- Do not attempt resuscitation (DNAR) orders
- Blunt, penetrating, or burn-related injury
- Patients with exsanguinations
- Known prisoners
- Known pregnancy
Show all 13Show fewer
- Non-ROC EMS agency/provider
- For Analyzing Late versus Early
- EMS-witnessed arrests
- Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)
- For ITD:
- Tracheostomy present
- CPR performed with the mechanical compression "Autopulse" device.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Alabama Resuscitation Center
Birmingham, Alabama, 35294
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, 97239
UCSD-San Diego Resuscitation Center
San Diego, California, 92103
Seattle-King County Center for Resuscitation Research, University of Washington
Seattle, Washington, 98195
Canada2 sites
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
Ottawa, Ontario, K1Y4E9
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
Toronto, Ontario, M5B1W8
About this study
Official title: Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.
Read the detailed description
The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.
The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.
Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.
- Conditions
- Heart Arrest
- Being tested
- Impedance Threshold Device (ITD), Sham ITD, Analyze early, Analyze later
- Keywords
- cardiac arrest, cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance Threshold Device (ITD)Device
Use of Impedance Threshold Device (ITD)
Sham ITDDevice
Sham ITD
Analyze earlyOther
Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.
Analyze laterOther
Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of Impedance Threshold Device (ITD) Receives: Device: Impedance Threshold Device (ITD) |
| 2 | Sham comparator | Sham ITD Receives: Device: Sham ITD |
| 3 | Other | 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. Receives: Other: Analyze early |
| 4 | Other | Analyze late. 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. Receives: Other: Analyze later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).
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.
Measured: Hospital discharge or death prior to discharge
Secondary outcomes (4)
Survival to Hospital Discharge
Measured: Survival to hospital discharge or death before discharge
Modified Rankin Score at 6 Months After Hospital Discharge
The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).
Measured: 6 months post hospital discharge
Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months
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.
Measured: 6 months post hospital discharge
Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months
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).
Measured: 6 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startJun 2007
- Primary completionNov 2009
- Study completionJul 2010
Why it stopped: Terminated because preliminary data suggested no difference in the strategies.
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 (8)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11,738 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), Canadian Institutes of Health Research (CIHR), Defence Research and Development Canada, Heart and Stroke Foundation of Canada, American Heart Association
- Responsible party
- Principal investigator, Susanne May, University of Washington
- Investigators
- Myron L Weisfeldt, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394706
- Sponsor's protocol ID
- 29919
- Other IDs
- HL077863
- Status last verified
- Jul 2018
- First submitted
- 30 Oct 2006
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.
PubMed 21879897Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya MR, Wang HE, Morrison LJ, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M; ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):787-97. doi: 10.1056/NEJMoa1010076.
PubMed 21879896Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.
PubMed 29310869Ho ML, Gatien M, Vaillancourt C, Whitham V, Stiell IG. Utility of prehospital electrocardiogram characteristics as prognostic markers in out-of-hospital pulseless electrical activity arrests. Emerg Med J. 2018 Feb;35(2):89-95. doi: 10.1136/emermed-2017-206878. Epub 2017 Oct 21.
PubMed 29055890Reynolds JC, Grunau BE, Rittenberger JC, Sawyer KN, Kurz MC, Callaway CW. Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation. 2016 Dec 20;134(25):2084-2094. doi: 10.1161/CIRCULATIONAHA.116.023309. Epub 2016 Oct 19.
PubMed 27760796Zheng R, Luo S, Liao J, Liu Z, Xu J, Zhan H, Liao X, Xiong Y, Idris A. Conversion to shockable rhythms is associated with better outcomes in out-of-hospital cardiac arrest patients with initial asystole but not in those with pulseless electrical activity. Resuscitation. 2016 Oct;107:88-93. doi: 10.1016/j.resuscitation.2016.08.008. Epub 2016 Aug 21.
PubMed 27554946Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.
PubMed 25565457Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.
PubMed 25252721
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
- ClinicalTrials.gov ID
- NCT00394706
- Acronym / sponsor ID
- 29919
- Conditions
- Heart Arrest
- Keywords
- cardiac arrest, cardiopulmonary resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated because preliminary data suggested no difference in the strategies.
- Enrolment
- 11,738 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), Canadian Institutes of Health Research (CIHR), Defence Research and Development Canada, Heart and Stroke Foundation of Canada, American Heart Association
- Study start
- Jun 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Nov 2006 (estimated)
- Results
- Posted 18 Apr 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 look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.
Detailed description
The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.
The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.
Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Impedance Threshold Device (ITD)Use of Impedance Threshold Device (ITD) |
| 2 | Sham comparator | Device: Sham ITDSham ITD |
| 3 | Other | Other: Analyze earlyAnalyze 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. |
| 4 | Other | Other: Analyze laterAnalyze late. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.
Key exclusion criteria (13 listed)
- Do not attempt resuscitation (DNAR) orders
- Blunt, penetrating, or burn-related injury
- Patients with exsanguinations
- Known prisoners
- Known pregnancy
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 |
|---|---|---|
| Impedance Threshold Device (ITD)Use of Impedance Threshold Device (ITD) | Device | 1 |
| Sham ITDSham ITD | Device | 2 |
| Analyze earlyUpon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required. | Other | 3 |
| Analyze laterUpon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. | Other | 4 |
Primary outcome
Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).
Time frame: Hospital discharge or death prior to discharge
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.
4 secondary outcomes
Survival to Hospital Discharge
Time frame: Survival to hospital discharge or death before discharge
Modified Rankin Score at 6 Months After Hospital Discharge
Time frame: 6 months post hospital discharge
Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months
Time frame: 6 months post hospital discharge
Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months
Time frame: 6 months post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21879897Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.
- Results publication: PubMed 21879896Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya MR, Wang HE, Morrison LJ, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M; ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):787-97. doi: 10.1056/NEJMoa1010076.
- Derived from this study: PubMed 29310869Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.
- Derived from this study: PubMed 29055890Ho ML, Gatien M, Vaillancourt C, Whitham V, Stiell IG. Utility of prehospital electrocardiogram characteristics as prognostic markers in out-of-hospital pulseless electrical activity arrests. Emerg Med J. 2018 Feb;35(2):89-95. doi: 10.1136/emermed-2017-206878. Epub 2017 Oct 21.
- Derived from this study: PubMed 27760796Reynolds JC, Grunau BE, Rittenberger JC, Sawyer KN, Kurz MC, Callaway CW. Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation. 2016 Dec 20;134(25):2084-2094. doi: 10.1161/CIRCULATIONAHA.116.023309. Epub 2016 Oct 19.
- Derived from this study: PubMed 27554946Zheng R, Luo S, Liao J, Liu Z, Xu J, Zhan H, Liao X, Xiong Y, Idris A. Conversion to shockable rhythms is associated with better outcomes in out-of-hospital cardiac arrest patients with initial asystole but not in those with pulseless electrical activity. Resuscitation. 2016 Oct;107:88-93. doi: 10.1016/j.resuscitation.2016.08.008. Epub 2016 Aug 21.
- Derived from this study: PubMed 25565457Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.
- Derived from this study: PubMed 25252721Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.
- Click here for more information about the ROC PRIMED TrialLink provided by the sponsor.
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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.
Myron L Weisfeldt, MD study chair
Johns Hopkins University
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Impedance Threshold Device (ITD), Analyze early and Analyze later in people with Heart Arrest, run by University of Washington at 9 sites in 2 countries.
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 1 inclusion and 13 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 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?
Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3). (time frame: Hospital discharge or death prior to 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 NCT00394706, which also lists 8 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 9 Aug 2018.