Recruiting
Phase 3

Zero Degree Positioning

Sponsor:

University of Tennessee

Code:

NCT03728738

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Head of Bed Positioning

Study Details

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.

Conditions

Ischemic Stroke

Study ID

NCT03728738

Start date

Sep 25, 2018

Status verified date

Mar, 2020

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zero Degree HOB

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

active comparator: Thirty Degree HOB

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stephanie Breuer, MS

901-448-6424sbreuer@uthsc.edu

Locations

Mobile Infirmary Medical Center

Recruiting

Mobile, Alabama, United States, 36607

Contacts

Jackie Owens, MSN

Jackie.Owens@InfirmaryHealth.org

Doctors Medical Center

Recruiting

Modesto, California, United States, 95350

Contacts

Dharati Trivedi, MS

Dharati.Trivedi@tenethealth.com

Northwestern Central DuPage Hospital

Recruiting

Winfield, Illinois, United States, 60190

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Saint Francis Health System

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Matthew Holzmann, MSN

MJHolzmann@saintfrancis.com

Hershey Medical Center - Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Alicia Richardson, MSN

arichardson2@pennstatehealth.psu.edu

Methodist University Hospital

Recruiting

Memphis, Tennessee, United States, 38104

Medical City - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Nicole Gonzales, MD

Nicole.R.Gonzales@uth.tmc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Mar 31, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Tennessee on 2020-03-31.