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Trial record 20 of 5988 for:    zero

Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke (ZODIAC)

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ClinicalTrials.gov Identifier: NCT03728738
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Anne Alexandrov, University of Tennessee Health Science Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Procedure: Head of Bed Positioning Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Zero Degree HOB
Randomization to zero degree head of bed positioning until the time of initiation of thrombectomy
Procedure: Head of Bed Positioning
The head of bed (HOB) position will be selected through computerized randomization, and will include either zero degree positioning or thirty degree HOB elevation

Active Comparator: Thirty Degree HOB
Randomization to thirty degree head of bed positioning until the time of initiation of thrombectomy
Procedure: Head of Bed Positioning
The head of bed (HOB) position will be selected through computerized randomization, and will include either zero degree positioning or thirty degree HOB elevation




Primary Outcome Measures :
  1. Early Neurologic Deterioration (END) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention [ Time Frame: Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first ]
    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.


Secondary Outcome Measures :
  1. Severe Neurological Deterioration (SND) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention [ Time Frame: Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first ]
    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.

  2. Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission [ Time Frame: Measured up until hospital discharge or day 7 (whichever comes first) ]
    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.

  3. Participant Deaths within 90-days from Stroke Onset [ Time Frame: Up until 90-days from stroke onset ]
    All cause death occurring from time of randomization up until 90-days from stroke onset

  4. National Institutes of Health Stroke Scale Score at Hospital Discharge or Day 7 [ Time Frame: Measured at hospital discharge or by day 7 (whichever comes first) ]
    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

  5. Modified Rankin Scale Score at Hospital Discharge or Day 7 [ Time Frame: Measured at hospital discharge or on day 7 (whichever comes first) ]
    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)

  6. Modified Rankin Scale Score at 90-days from Stroke Onset [ Time Frame: Measured 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke symptoms consistent with large artery occlusion
  • Baseline standard of care non-contrast head CT (or MRI) negative for hemorrhage or mass-effect
  • Evidence of arterial occlusion on standard of care CT angiography or MR angiography
  • Favorable neuroimaging (Alberta Stroke Program Early Computed Tomography Score [ASPECTS] > 6 in anterior circulation stroke; not applicable in posterior circulation stroke)
  • Ordered treatment with mechanical thrombectomy
  • Pre-stroke baseline modified Rankin Score (mRS) < 1
  • Ability to enroll, randomize and begin the intervention within the Emergency Department

Exclusion Criteria:

  • Non-English speaking subjects will be excluded due to use of English language instruments (modified Rankin Scale [mRS] & NIHSS) and English speaking investigators
  • Pregnancy or suspicion of pregnancy
  • Evidence or suspicion of vomiting any time prior to consent which could predispose to aspiration pneumonia and therefore confound determination of protocol safety
  • Anticipated palliative care referral
  • Evidence of evolving malignant infarction on admission noncontrast CT (or MRI)
  • Need for intubation with mechanical ventilation, or non-invasive ventilatory support with either bi-level positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP)
  • Inability to tolerate zero-degree positioning due to congestive heart failure, preexisting pneumonia, chronic obstructive pulmonary disease, or other medical condition
  • Admission chest radiograph positive for pleural effusion, pulmonary edema, pneumonia, or other pulmonary condition that may confound determination of protocol safety
  • Abnormal breath sounds on admission assessment that may confound determination of protocol safety
  • Lack of a telephone and/or permanent address predisposing patients to be lost to follow up
  • Enrollment in another clinical trial that may affect our primary or secondary endpoints
  • In the absence of a consenting legal next of kin, any medical, psychological, cognitive, social or legal condition that would interfere with informed consent and/or capacity to comply with all study requirements, including the necessary time commitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728738


Contacts
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Contact: Stephanie Breuer, MS 901-448-6424 sbreuer@uthsc.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: David Liebeskind, MD         
United States, Illinois
Northwestern Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Abbigayle Doerr, DNP         
United States, Kansas
Via Christi Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: LeighAnn Persondek, MSN         
United States, Kentucky
University of Louisville Hospital Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Betsy Wise, MSN         
United States, North Carolina
Moses Cone Medical Center Not yet recruiting
Greensboro, North Carolina, United States, 27401
Contact: Sharon Biby, MSN         
United States, Oklahoma
Mercy Medical Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Amberlee Elliott, MSN         
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Anne W Alexandrov, PhD         
United States, Texas
Medical City - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Cara Guthrie-Chu, MSN         
Sponsors and Collaborators
University of Tennessee Health Science Center
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Anne W Alexandrov, PhD University of Tennessee Health Science Center at Memphis

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Responsible Party: Anne Alexandrov, Professor of Nursing & Professor of Neurology, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT03728738     History of Changes
Other Study ID Numbers: 1R01NR017850-01 ( U.S. NIH Grant/Contract )
1R01NR017850-01 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia