NCT03728738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_3

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

October 23, 2018

Last Update Submit

March 28, 2020

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Severe Neurological Deterioration (SND) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention

    Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first

  • Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission

    Measured up until hospital discharge or day 7 (whichever comes first)

  • Participant Deaths within 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

    Measured at hospital discharge or by day 7 (whichever comes first)

  • Modified Rankin Scale Score at Hospital Discharge or Day 7

    Measured at hospital discharge or on day 7 (whichever comes first)

  • +1 more secondary outcomes

Study Arms (2)

Zero Degree HOB

EXPERIMENTAL

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

Procedure: Head of Bed Positioning

Thirty Degree HOB

ACTIVE COMPARATOR

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

Procedure: Head of Bed Positioning

Interventions

Head of Bed PositioningPROCEDURE

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 HOBZero Degree HOB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Doctors Medical Center

Modesto, California, 95350, United States

RECRUITING

Northwestern Central DuPage Hospital

Winfield, Illinois, 60190, United States

RECRUITING

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Moses Cone Medical Center

Greensboro, North Carolina, 27401, United States

NOT YET RECRUITING

Saint Francis Health System

Tulsa, Oklahoma, 74136, United States

RECRUITING

Hershey Medical Center - Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

Methodist University Hospital

Memphis, Tennessee, 38104, United States

RECRUITING

Medical City - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40465238DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne W Alexandrov, PhD

    University of Tennessee Health Science Center at Memphis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Breuer, MS

CONTACT

901-448-6424sbreuer@uthsc.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing & Professor of Neurology

Study Record Dates

First Submitted

October 23, 2018

First Posted

November 2, 2018

Study Start

September 25, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

US(11)