Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke

Last updated: March 28, 2020
Sponsor: University of Tennessee Health Science Center
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Blood Clots

Cardiac Ischemia

Treatment

N/A

Clinical Study ID

NCT03728738
1R01NR017850-01
1R01NR017850-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ischemic stroke symptoms consistent with large artery occlusion

  • Baseline standard of care non-contrast head CT (or MRI) negative for hemorrhage ormass-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 circulationstroke)

  • Ordered treatment with mechanical thrombectomy

  • Pre-stroke baseline modified Rankin Score (mRS) < 1

  • Ability to enroll, randomize and begin the intervention within the EmergencyDepartment

Exclusion

Exclusion Criteria:

  • Non-English speaking subjects will be excluded due to use of English languageinstruments (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 toaspiration 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 supportwith either bi-level positive airway pressure (BiPAP) or continuous positive airwaypressure (CPAP)

  • Inability to tolerate zero-degree positioning due to congestive heart failure,preexisting pneumonia, chronic obstructive pulmonary disease, or other medicalcondition

  • 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 ofprotocol safety

  • Lack of a telephone and/or permanent address predisposing patients to be lost tofollow up

  • Enrollment in another clinical trial that may affect our primary or secondaryendpoints

  • 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/orcapacity to comply with all study requirements, including the necessary timecommitment

Study Design

Total Participants: 182
Study Start date:
September 25, 2018
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36607
    United States

    Active - Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Doctors Medical Center

    Modesto, California 95350
    United States

    Active - Recruiting

  • Northwestern Central DuPage Hospital

    Winfield, Illinois 60190
    United States

    Active - Recruiting

  • Via Christi Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Moses Cone Medical Center

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Mercy Medical Center

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Saint Francis Health System

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Hershey Medical Center - Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Methodist University Hospital

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Medical City - Fort Worth

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

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