Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
Status unconfirmed · Phase 3
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT03728738
- Run by
- University of Tennessee
- People needed
- 182
- Starts
- 2018-09-25
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2020-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mobile Infirmary Medical Center — Mobile, Alabama, United States (enrolling)
- Medical City - Fort Worth — Fort Worth, Texas, United States (enrolling)
- Memorial Hermann Hospital — Houston, Texas, United States (enrolling)
- Doctors Medical Center — Modesto, California, United States (enrolling)
- Northwestern Central DuPage Hospital — Winfield, Illinois, United States (enrolling)
- University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
- Saint Francis Health System — Tulsa, Oklahoma, United States (enrolling)
- Hershey Medical Center - Penn State Health — Hershey, Pennsylvania, United States (enrolling)
- Methodist University Hospital — Memphis, Tennessee, United States (enrolling)
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- Moses Cone Medical Center — Greensboro, North Carolina, United States
Full record on ClinicalTrials.gov
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