Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03728738
Study type Interventional
Source University of Tennessee Health Science Center
Contact Stephanie Breuer, MS
Phone 901-448-6424
Email sbreuer@uthsc.edu
Status Recruiting
Phase Phase 3
Start date September 25, 2018
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders N/A
Recruiting NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Not yet recruiting NCT01923818 - Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events Phase 2/Phase 3
Suspended NCT01852201 - POSITIVE Stroke Clinical Trial N/A
Completed NCT01968122 - Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China N/A
Completed NCT01983644 - RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study N/A
Completed NCT02924168 - Radial Shock Waves for Functional Disability in Stroke N/A
Completed NCT01949948 - Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke Phase 3
Completed NCT02184936 - Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke N/A
Recruiting NCT01526824 - Lovaza's Effect on Clopidogrel in a Neuro Population Phase 0
Completed NCT02121327 - The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke N/A
Completed NCT01193569 - A Study of Survival and Outcome After Stroke