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| Name | Class |
|---|---|
| Charles F. Kettering Foundation | UNKNOWN |
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Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
|
| Control Group | Sham Comparator | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Remote Ischemic Conditioning | Device | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition | Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation. | Completion of their allocated study intervention, an average of 30 minutes from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success | Treatment Success assessed as the proportion of intervention group patients who remain alive and on their allocated therapy for the intended study duration. | 30 minutes from initiation of study intervention |
| Cardiac Function |
| Measure | Description | Time Frame |
|---|---|---|
| Device Failure | device failure will be defined as discontinuation of use of the device prior to the end of allocated treatment interval because of mechanical failure as opposed to provider preference. | 30 minutes from initiation of study intervention |
| Expected Adverse Event Related to Device- Pain |
Included will be those with:
Excluded will be those with:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Nichol, MD, MPH | University of Washington | Principal Investigator |
| Emilby S Bartlett, MD MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graham Nichol | Seattle | Washington | 98104 | United States |
Available upon request, subject to mutual agreement
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Study recruitment occurred from July 01, 2020, to February 03, 2022. Recruitment ceased when target enrollment (30 participants) was achieved. This study was conducted under exception from informed consent (EFIC) for emergency research. Eligible subjects were randomized with masked allocation to control (standard care) versus intervention (standard care and RIC) following OHCA at a single site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. Active Remote Ischemic Conditioning: A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
| FG001 | Control Group | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. Sham Remote Ischemic Conditioning: The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. Active Remote Ischemic Conditioning: A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attrition | Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation. | Posted | Count of Participants | Participants | Completion of their allocated study intervention, an average of 30 minutes from enrollment |
|
30 days after cardiac arrest.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. Active Remote Ischemic Conditioning: A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary occlusion of IV in the Emergency Department | Injury, poisoning and procedural complications | Non-systematic Assessment | A single patient (6%) in the intervention group had transient occlusion of their upper extremity intravenous line, which immediately resolved on repositioning of the blood pressure cuff. |
This was a single-center pilot study. The rate of incomplete application of the intervention may be higher in a multi-center study. It lacked power to detect significant differences in outcomes, and did not include immunologic markers or markers of cardiac or brain injury. It assessed feasibility of the intervention rather than to assess whether RIC achieved a significant difference in biomarkers or clinical outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graham Nichol | University of Washington | 206 521 1784 | nichol@uw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2019 | Sep 30, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
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Patients and investigators will be masked to treatment assignment up to the point of randomization.
|
| Sham Remote Ischemic Conditioning | Device | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
|
Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications.
| Within 48 hours of index arrest |
| Proportion With Cardiogenic Shock, % | Cardiogenic Shock assessed as systolic BP < 80 mmHg during any 6 h period within 48 h of the index arrest not due to a correctable cause, and treated with pressors or inotropes or placement of a mechanical cardiac assist device (e.g. intra-aortic balloon pump). Cardiogenic shock correlates with survival after resuscitation from cardiac arrest. | Within 48 hours of index arrest |
| STEMI | STEMI assessed as the presence of electrocardiographic (ECG) and biomarker criteria for acute myocardial infarction within 48 h of the index arrest. Note that ST-elevation on the first 12-lead ECG after resuscitation is a poor predictor of acute infarction in this population. These patients often develop infarctions during the subsequent 48 h. | Within 48 hours of index arrest |
| Myocardial Injury | Myocardial Injury assessed as peak serum troponin in ng/mL at any time point within 24 h of index arrest. | Within 24 hours of index arrest |
| Renal Dysfunction | Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria. | Within 24 hours of index arrest |
| Hospital Free Survival | Hospital Free Survival (HFS) assessed as number of days alive and permanently out of hospital up to 30 days post arrest | Within 30 days of index arrest |
| Withdrawal of Care | assessed as the reduction of support (i.e. reducing pressors, lab draws or medications) or withdrawal of support (i.e. extubation, stopping drips/meds, changing to comfort care only) during hospitalization. | Discharge or 30 days after index arrest |
| Favourable Neurologic Status at Discharge | Favourable Neurologic Status at Discharge assessed using modified Rankin Score (MRS) < 3 at hospital discharge or 30 days after index arrest. Modified Rankin Scale is scored from zero to six. Higher values represent a worse outcome. Favorable neurologic status is defined as a modified Rankin score 0, 1 or 2. | Discharge or 30 days after index arrest |
| Survival to Discharge | Survival to Discharge assessed as alive when discharged from hospital to home, nursing facility or rehabilitation. Patients transferred to another acute care facility (e.g. to undergo implantable defibrillator placement) will be considered still hospitalized. | Discharge or 30 days after index arrest |
| Clinical Instability at Discharge | Clinical Instability at Discharge assessed using the Kosecoff Index measured at discharge based on the presence of nine symptoms and signs associated with increased risk of rehospitalization. Instability will be the presence of any of these. Clinical instability at discharge was defined by the Kosecoff Index. https://pubmed.ncbi.nlm.nih.gov/2214063/ This was scored as 1 point for the presence and 0 for the absence of each of the following during the 24 h prior to discharge: Fever, temperature >38.3°C Urinary incontinence Chest pain Shortness of breath Confusion Heart rate >=130 beats/min Respiratory rate >=30/min Diastolic blood pressure >= 105 mmHg Systolic blood pressure < 90 mmHg Heart rate < 50 bpm Premature ventricular contractions on telemetry | Discharge or 30 days after index arrest |
| Survival to 30 Days After Arrest | Survival to 30 Days After Cardiac Arrest assessed as alive 30 days after the index cardiac arrest as confirmed by a brief telephone interview. | 30 days after index arrest |
| Accrual | Accrual is the proportion of eligible subjects who have the study device applied | Before leaving the emergency department |
Pain assessed using the Richmond Agitation-Sedation Scale at 30 and 60 minutes after randomization in control and intervention group patients. No gold standard exists for pain assessment in sedated and ventilated patients. |
| Within 24 hours of Enrollment |
| Expected Adverse Event Related to Device- Thrombophlebitis | Thrombophlebitis assessed as symptomatic non central nervous system venous or arterial thrombus documented radiographically or ultrasonographically in the upper extremity to which the study intervention was applied. | Within 1 week of Enrollment |
| Expected Adverse Event Related to Device- Sepsis | Sepsis assessed within one week of index arrest as either i) the presence of microbiologically proven, clinically proven, or suspected infection; or ii) presence of Systemic Inflammatory Response Syndrome (SIRS); and iii) development of at least one organ dysfunction within the preceding 24 hours. | Within 1 week of Enrollment |
| Expected Adverse Event Related to Cardiac Arrest | Related to Cardiac Arrest The following are commonly observed in patients who experience cardiac arrest, and may or may not be attributable to specific resuscitation therapies. These will be monitored and reported but not classified as serious adverse events. Clinical diagnoses of pneumonia, cerebral bleeding, stroke, seizures, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, serious rib fractures, sternal fractures, internal thoracic or abdominal injuries as noted in the hospital discharge summary. | Discharge or 30 days after index arrest |
| Unexpected Adverse Event | These will be defined as any serious unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in the investigation plan or application, or any other unexpected serious problem associated with a device that relates to the rights, safety or welfare of subjects. Death or neurological impairment will not be considered an adverse event in this study, as it is an expected part of the natural history of the illness for a large proportion of the population. | Discharge or 30 days after index arrest |
| BG001 | Control Group | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. Sham Remote Ischemic Conditioning: The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Control Group | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. Sham Remote Ischemic Conditioning: The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
|
|
| Secondary | Treatment Success | Treatment Success assessed as the proportion of intervention group patients who remain alive and on their allocated therapy for the intended study duration. | Posted | Count of Participants | Participants | 30 minutes from initiation of study intervention |
|
|
|
| Secondary | Cardiac Function | Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications. | This analysis is based on the number of participants with an LVEF recorded. | Posted | Mean | Standard Deviation | % of left ventricular ejection fraction | Within 48 hours of index arrest |
|
|
|
| Secondary | Proportion With Cardiogenic Shock, % | Cardiogenic Shock assessed as systolic BP < 80 mmHg during any 6 h period within 48 h of the index arrest not due to a correctable cause, and treated with pressors or inotropes or placement of a mechanical cardiac assist device (e.g. intra-aortic balloon pump). Cardiogenic shock correlates with survival after resuscitation from cardiac arrest. | Posted | Count of Participants | Participants | Within 48 hours of index arrest |
|
|
|
| Secondary | STEMI | STEMI assessed as the presence of electrocardiographic (ECG) and biomarker criteria for acute myocardial infarction within 48 h of the index arrest. Note that ST-elevation on the first 12-lead ECG after resuscitation is a poor predictor of acute infarction in this population. These patients often develop infarctions during the subsequent 48 h. | One participant in the control group did not have data recorded for this metric (unknown) and was not included in the analysis. | Posted | Count of Participants | Participants | Within 48 hours of index arrest |
|
|
|
| Secondary | Myocardial Injury | Myocardial Injury assessed as peak serum troponin in ng/mL at any time point within 24 h of index arrest. | Participants with an elevated serum troponin (>0.03) were included in the analysis. | Posted | Mean | Standard Deviation | peak serum troponin level | Within 24 hours of index arrest |
|
|
|
| Secondary | Renal Dysfunction | Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria. | In order to calculate the RIFLE score, both a baseline creatinine level (prior to the index cardiac arrest) and a first recorded creatinine level (after the index cardiac arrest) were required. Only those participants with both creatinine values were included in the analysis. For this analysis, participants with a creatinine level which was 1.5 times above baseline or more were counted as positive for AKI. | Posted | Count of Participants | Participants | Within 24 hours of index arrest |
|
|
|
| Secondary | Hospital Free Survival | Hospital Free Survival (HFS) assessed as number of days alive and permanently out of hospital up to 30 days post arrest | Posted | Mean | Standard Deviation | days | Within 30 days of index arrest |
|
|
|
| Secondary | Withdrawal of Care | assessed as the reduction of support (i.e. reducing pressors, lab draws or medications) or withdrawal of support (i.e. extubation, stopping drips/meds, changing to comfort care only) during hospitalization. | There was missing data on the participants not included in this analysis. | Posted | Count of Participants | Participants | Discharge or 30 days after index arrest |
|
|
|
| Secondary | Favourable Neurologic Status at Discharge | Favourable Neurologic Status at Discharge assessed using modified Rankin Score (MRS) < 3 at hospital discharge or 30 days after index arrest. Modified Rankin Scale is scored from zero to six. Higher values represent a worse outcome. Favorable neurologic status is defined as a modified Rankin score 0, 1 or 2. | Posted | Median | Inter-Quartile Range | Modified Rankin Score | Discharge or 30 days after index arrest |
|
|
|
| Secondary | Survival to Discharge | Survival to Discharge assessed as alive when discharged from hospital to home, nursing facility or rehabilitation. Patients transferred to another acute care facility (e.g. to undergo implantable defibrillator placement) will be considered still hospitalized. | Posted | Count of Participants | Participants | Discharge or 30 days after index arrest |
|
|
|
| Secondary | Clinical Instability at Discharge | Clinical Instability at Discharge assessed using the Kosecoff Index measured at discharge based on the presence of nine symptoms and signs associated with increased risk of rehospitalization. Instability will be the presence of any of these. Clinical instability at discharge was defined by the Kosecoff Index. https://pubmed.ncbi.nlm.nih.gov/2214063/ This was scored as 1 point for the presence and 0 for the absence of each of the following during the 24 h prior to discharge: Fever, temperature >38.3°C Urinary incontinence Chest pain Shortness of breath Confusion Heart rate >=130 beats/min Respiratory rate >=30/min Diastolic blood pressure >= 105 mmHg Systolic blood pressure < 90 mmHg Heart rate < 50 bpm Premature ventricular contractions on telemetry | Participants were included in this analysis if they survived to discharge. Three participants (all from the control group) were missing data on this metric and were also excluded from the analysis. | Posted | Count of Participants | Participants | Discharge or 30 days after index arrest |
|
|
|
| Secondary | Survival to 30 Days After Arrest | Survival to 30 Days After Cardiac Arrest assessed as alive 30 days after the index cardiac arrest as confirmed by a brief telephone interview. | Posted | Count of Participants | Participants | 30 days after index arrest |
|
|
|
| Secondary | Accrual | Accrual is the proportion of eligible subjects who have the study device applied | Posted | Count of Participants | Participants | Before leaving the emergency department |
|
|
|
| Other Pre-specified | Device Failure | device failure will be defined as discontinuation of use of the device prior to the end of allocated treatment interval because of mechanical failure as opposed to provider preference. | Posted | Count of Participants | Participants | 30 minutes from initiation of study intervention |
|
|
|
| Other Pre-specified | Expected Adverse Event Related to Device- Pain | Pain assessed using the Richmond Agitation-Sedation Scale at 30 and 60 minutes after randomization in control and intervention group patients. No gold standard exists for pain assessment in sedated and ventilated patients. | Posted | Count of Participants | Participants | Within 24 hours of Enrollment |
|
|
|
| Other Pre-specified | Expected Adverse Event Related to Device- Thrombophlebitis | Thrombophlebitis assessed as symptomatic non central nervous system venous or arterial thrombus documented radiographically or ultrasonographically in the upper extremity to which the study intervention was applied. | Posted | Count of Participants | Participants | Within 1 week of Enrollment |
|
|
|
| Other Pre-specified | Expected Adverse Event Related to Device- Sepsis | Sepsis assessed within one week of index arrest as either i) the presence of microbiologically proven, clinically proven, or suspected infection; or ii) presence of Systemic Inflammatory Response Syndrome (SIRS); and iii) development of at least one organ dysfunction within the preceding 24 hours. | Posted | Count of Participants | Participants | Within 1 week of Enrollment |
|
|
|
| Other Pre-specified | Expected Adverse Event Related to Cardiac Arrest | Related to Cardiac Arrest The following are commonly observed in patients who experience cardiac arrest, and may or may not be attributable to specific resuscitation therapies. These will be monitored and reported but not classified as serious adverse events. Clinical diagnoses of pneumonia, cerebral bleeding, stroke, seizures, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, serious rib fractures, sternal fractures, internal thoracic or abdominal injuries as noted in the hospital discharge summary. | Participants were included in this analysis if they survived to discharge. Also excluded were 3 participant (all from the control group) with missing data. | Posted | Count of Participants | Participants | Discharge or 30 days after index arrest |
|
|
|
| Other Pre-specified | Unexpected Adverse Event | These will be defined as any serious unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in the investigation plan or application, or any other unexpected serious problem associated with a device that relates to the rights, safety or welfare of subjects. Death or neurological impairment will not be considered an adverse event in this study, as it is an expected part of the natural history of the illness for a large proportion of the population. | Posted | Count of Participants | Participants | Discharge or 30 days after index arrest |
|
|
|
| 9 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Control Group | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. Sham Remote Ischemic Conditioning: The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. | 8 | 14 | 0 | 14 | 0 | 14 |
|
Not provided
Not provided
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|