Clinical trial NCT03728738: Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
Official title: Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemic Stroke
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-11-02
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Early Neurologic Deterioration (END) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention
timeFrame: Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first
Secondary outcomes:
measure: Severe Neurological Deterioration (SND) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention
timeFrame: Measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first
measure: Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission
timeFrame: Measured up until hospital discharge or day 7 (whichever comes first)
measure: Participant Deaths within 90-days from Stroke Onset
timeFrame: Up until 90-days from stroke onset
measure: National Institutes of Health Stroke Scale Score at Hospital Discharge or Day 7
timeFrame: Measured at hospital discharge or by day 7 (whichever comes first)
measure: Modified Rankin Scale Score at Hospital Discharge or Day 7
timeFrame: Measured at hospital discharge or on day 7 (whichever comes first)
measure: Modified Rankin Scale Score at 90-days from Stroke Onset
timeFrame: Measured at 90 days from Stroke Onset
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Modesto
country: United States
facility: Doctors Medical Center
state: California
city: Winfield
country: United States
facility: Northwestern Central DuPage Hospital
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Greensboro
country: United States
facility: Moses Cone Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Saint Francis Health System
state: Oklahoma
city: Hershey
country: United States
facility: Hershey Medical Center - Penn State Health
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Fort Worth
country: United States
facility: Medical City - Fort Worth
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: University of Tennessee Health Science Center at Memphis
name: Anne W Alexandrov, PhD
role: PRINCIPAL_INVESTIGATOR
References: