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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR017850-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Placing the head of bed (HOB) at 0-degrees has been shown in small studies to improve blood flow to the brain in patients with ischemic stroke caused by large artery occlusions, thereby reducing stroke symptom worsening. This simple yet potentially impactful intervention has yet to be tested in a large clinical trial in hyperacute large artery ischemic stroke patients, but may provide nurses with a powerful contribution to acute stroke care that is capable of preventing worsening of stroke symptoms and promoting stabilization. Because stroke is the leading cause of preventable long-term disability in adults, this study may show that simple methods such as 0-degree HOB positioning should be considered one of the very first actions taken in the emergent management of acute ischemic stroke patients.
Positioning of the patient during hyperacute ischemic stroke (AIS) treatment is an important, yet understudied aspect of nursing care that could impact the course of treatment and clinical outcome. Since 1968, clinical symptom worsening in AIS patients has been documented with the head of bed (HOB) elevated to 30 degrees or higher, while clinical improvement or symptom stability has been noted with zero degree HOB positioning. Mechanisms for zero degree HOB clinical improvement include favorable gravitational blood flow conditions and recruitment of collateral blood channels, while in the case of treatment with clot-busting medications, increased blood flow may allow more medication to reach occluded arteries facilitating clot breakdown. Despite this, there is currently divide within the clinical community about what position is best for patients, although it has been argued that zero degree head positioning should be among the first steps taken to improve blood flow to the brain and prevent stroke symptom worsening. The investigators have shown that elevated ICP is absent in early AIS, and that pneumonia is rare using these piloted methods. However, no large clinical trial has examined efficacy and safety of zero degree HOB positioning within hyperacute large vessel occlusion (LVO) ischemic stroke patients with potentially viable brain tissue, leaving the acute stroke community confused as to what constitutes best practice. ZODIAC is a prospective randomized open blinded endpoint (PROBE) clinical trial of head positioning to determine if zero degree HOB positioning during the early phase of hyperacute LVO ischemic stroke management prevents neurological symptom worsening. Mechanical thrombectomy (MT) eligible patients (n=182) will be randomized to one of two groups: 1) Zero degree HOB positioning; or, 2) thirty degree HOB positioning. The hypothesis is that optimal HOB position can be determined by early neurological symptom worsening during the intervention (Aim 1) prior to initiation of the thrombectomy procedure, and the investigators propose that real-time deterioration may be a surrogate measure for decreased downstream perfusion, potentially impacting viability of brain at risk for infarction. Aim 2 will confirm that use of zero degree HOB positioning for AIS is safe. Use of this nursing measure holds significant promise as an innovative adjunct method to improve AIS symptoms, and ultimately reduce disability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero Degree HOB | Experimental | Randomization to zero degree head of bed positioning until the time of initiation of thrombectomy |
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| Thirty Degree HOB | Active Comparator | Randomization to thirty degree head of bed positioning until the time of initiation of thrombectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head of Bed Positioning | Procedure | The head of bed (HOB) position will be selected through computerized randomization, and will include either zero degree positioning or thirty degree HOB elevation |
| Measure | Description | Time Frame |
|---|---|---|
| Early Neurologic Deterioration (END) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention | Two or more point-worsening in the National Institute of Health Stroke Scale (stroke disability severity measure, ranging from 0-no disability, to 42-severely disabled) score during the positioning intervention period. | Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Neurological Deterioration (SND) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention | Four or more point-worsening in the National Institute of Health Stroke Scale (stroke disability severity measure, ranging from 0-no disability, to 42-severely disabled) score during the positioning intervention period. | Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Breuer, MS | Contact | 901-448-6424 | sbreuer@uthsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anne W Alexandrov, PhD | University of Tennessee Health Science Center at Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Recruiting | Mobile | Alabama | 36607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40465238 | Derived | Alexandrov AW, Shearin AJ, Mandava P, Torrealba-Acosta G, Elangovan C, Krishnaiah B, Nearing K, Robinson E, Guthrie-Chu C, Holzmann M, Fill B, Trivedi DR, Richardson A, Middleton S, Brewer BB, Liebeskind DS, Goyal N, Grotta JC, Alexandrov AV; ZODIAC Investigators. Optimal Head-of-Bed Positioning Before Thrombectomy in Large Vessel Occlusion Stroke: A Randomized Clinical Trial. JAMA Neurol. 2025 Sep 1;82(9):905-914. doi: 10.1001/jamaneurol.2025.2253. |
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Prospective randomized open blinded endpoint (PROBE) clinical trial using clinical assessors blinded to the intervention to determine neurologic deterioration on the NIH Stroke Scale Score following positioning to either zero degree or thirty degree heights.
| Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission | Documented onset of a new or progressive infiltrate on pulmonary imaging along with the presence of at least two of the following - Fever of 38°C/100.4°F; Purulent sputum; Leukocytosis or leukopenia; and/or, Decline in oxygen saturation. | Measured up until hospital discharge or day 7 (whichever comes first) |
| Participant Deaths within 90-days from Stroke Onset | All cause death occurring from time of randomization up until 90-days from stroke onset | Up until 90-days from stroke onset |
| National Institutes of Health Stroke Scale Score at Hospital Discharge or Day 7 | Total National Institute of Health Stroke Scale (stroke disability severity measure, ranging from 0-no disability, to 42-severely disabled) score measured at the time of hospital discharge or on day 7 | Measured at hospital discharge or by day 7 (whichever comes first) |
| Modified Rankin Scale Score at Hospital Discharge or Day 7 | Categorical rank on the Modified Rankin Scale score (stroke functional outcome measure ranging from 0-no functional disability, to 6-dead) measured at the time of hospital discharge or on day 7 (whichever comes first) | Measured at hospital discharge or on day 7 (whichever comes first) |
| Modified Rankin Scale Score at 90-days from Stroke Onset | Categorical rank on the Modified Rankin Scale score (stroke functional outcome measure ranging from 0-no functional disability, to 6-dead) measured at 90 days from stroke onset | Measured at 90 days from Stroke Onset |
| Ronald Reagan UCLA Medical Center | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Doctors Medical Center | Recruiting | Modesto | California | 95350 | United States |
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| Northwestern Central DuPage Hospital | Recruiting | Winfield | Illinois | 60190 | United States |
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| University of Louisville Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Moses Cone Medical Center | Not yet recruiting | Greensboro | North Carolina | 27401 | United States |
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| Saint Francis Health System | Recruiting | Tulsa | Oklahoma | 74136 | United States |
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| Hershey Medical Center - Penn State Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Methodist University Hospital | Recruiting | Memphis | Tennessee | 38104 | United States |
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| Medical City - Fort Worth | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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