Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke

NCT ID: NCT03728738

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zero Degree HOB

Randomization to zero degree head of bed positioning until the time of initiation of thrombectomy

Group Type: EXPERIMENTAL

Head of Bed Positioning

Intervention Type: 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

Thirty Degree HOB

Randomization to thirty degree head of bed positioning until the time of initiation of thrombectomy

Group Type: ACTIVE_COMPARATOR

Head of Bed Positioning

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Anne Alexandrov

Professor of Nursing & Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne W Alexandrov, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Health Science Center at Memphis

Locations

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status: RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status: NOT_YET_RECRUITING

Doctors Medical Center

Modesto, California, United States

Site Status: RECRUITING

Northwestern Central DuPage Hospital

Winfield, Illinois, United States

Site Status: RECRUITING

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status: RECRUITING

Moses Cone Medical Center

Greensboro, North Carolina, United States

Site Status: NOT_YET_RECRUITING

Saint Francis Health System

Tulsa, Oklahoma, United States

Site Status: RECRUITING

Hershey Medical Center - Penn State Health

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Methodist University Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Medical City - Fort Worth

Fort Worth, Texas, United States

Site Status: RECRUITING

Memorial Hermann Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Breuer, MS

Role: CONTACT

sbreuer@uthsc.edu

901-448-6424

Facility Contacts

Jackie Owens, MSN

Role: primary

Jackie.Owens@InfirmaryHealth.org

David Liebeskind, MD

Role: primary

Dharati Trivedi, MS

Role: primary

Dharati.Trivedi@tenethealth.com

Abbigayle Doerr, DNP

Role: primary

Betsy Wise, MSN

Role: primary

Sharon Biby, MSN

Role: primary

Matthew Holzmann, MSN

Role: primary

MJHolzmann@saintfrancis.com

Alicia Richardson, MSN

Role: primary

arichardson2@pennstatehealth.psu.edu

Anne W Alexandrov, PhD

Role: primary

Cara Guthrie-Chu, MSN

Role: primary

Nicole Gonzales, MD

Role: primary

Nicole.R.Gonzales@uth.tmc.edu

References

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.

Reference Type: DERIVED

PMID: 40465238 (View on PubMed)

Other Identifiers

1R01NR017850-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R01NR017850-01

Identifier Type: NIH

Identifier Source: org_study_id

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