Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke

Ischemic Stroke Clinical Trial

— ZODIAC  

Official title:

Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728738
• Other study ID #: 1R01NR017850-01
• Secondary ID: 1R01NR017850-01
• Status: Recruiting
• Phase: Phase 3
• Start date: September 25, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2020
• Source: University of Tennessee Health Science Center
• Contact: Stephanie Breuer, MS
• Phone: 901-448-6424
• Email: sbreuer[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Medical City - Fort Worth	Fort Worth	Texas
United States	Moses Cone Medical Center	Greensboro	North Carolina
United States	Hershey Medical Center - Penn State Health	Hershey	Pennsylvania
United States	Memorial Hermann Hospital	Houston	Texas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Methodist University Hospital	Memphis	Tennessee
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Doctors Medical Center	Modesto	California
United States	Saint Francis Health System	Tulsa	Oklahoma
United States	Northwestern Central DuPage Hospital	Winfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee Health Science Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severe Neurological Deterioration (SND) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention	Four 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	Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission	Documented onset of a new or progressive infiltrate on pulmonary imaging along with the presence of at least two of the following - Fever of 38°C/100.4°F; Purulent sputum; Leukocytosis or leukopenia; and/or, Decline in oxygen saturation.	Measured up until hospital discharge or day 7 (whichever comes first)
Secondary	Participant Deaths within 90-days from Stroke Onset	All cause death occurring from time of randomization up until 90-days from stroke onset	Up until 90-days from stroke onset
Secondary	National Institutes of Health Stroke Scale Score at Hospital Discharge or Day 7	Total National Institute of Health Stroke Scale (stroke disability severity measure, ranging from 0-no disability, to 42-severely disabled) score measured at the time of hospital discharge or on day 7	Measured at hospital discharge or by day 7 (whichever comes first)
Secondary	Modified Rankin Scale Score at Hospital Discharge or Day 7	Categorical rank on the Modified Rankin Scale score (stroke functional outcome measure ranging from 0-no functional disability, to 6-dead) measured at the time of hospital discharge or on day 7 (whichever comes first)	Measured at hospital discharge or on day 7 (whichever comes first)
Secondary	Modified Rankin Scale Score at 90-days from Stroke Onset	Categorical rank on the Modified Rankin Scale score (stroke functional outcome measure ranging from 0-no functional disability, to 6-dead) measured at 90 days from stroke onset	Measured at 90 days from Stroke Onset