Stroke is the second leading cause of death and the third leading cause of disability worldwide, with an increasing incidence. Reperfusion therapy after cerebral ischemia is one of the most practical and effective treatments for ischemic stroke globally. However, the nursing care and management of hemodynamics during the acute phase after reperfusion therapy for ischemic stroke have always been key and challenging aspects of clinical work. Stable hemodynamic status can prevent hypoperfusion or hyperperfusion of brain tissue, reduce damage to the ischemic core and penumbra areas, and consequently decrease cerebral edema, elevated intracranial pressure, and the associated neurological damage and worsening clinical outcomes. Head positioning, as a simple, economical, and effective adjunctive treatment for managing patients undergoing reperfusion therapy, has gradually received attention. During the acute phase of stroke, brain tissue is in a state of ischemia and hypoxia. Lying flat may increase blood and oxygen supply to the brain tissue, providing a certain degree of protection, but it may also have some impact on swallowing and lung function. Raising the head of the bed can help venous blood return from the head and may reduce cerebral edema to some extent, but it can also affect perfusion of ischemic brain tissue to a certain degree. In the acute phase after successful reperfusion, it remains a clinical challenge to maintain stable cerebral blood supply (hemodynamic stability) through nursing care. Head positioning (lying flat or elevating the head of the bed) is a simple, economical nursing measure that may affect cerebral blood flow. However, for severely affected stroke patients like you, there is no clear international consensus on whether maintaining a flat position (0°) or elevating the head of the bed 30° within the first 24 hours after treatment is more beneficial for long-term recovery. Previous studies have shown inconsistent results, so more rigorous research is needed to answer this question. The primary purpose of this study is to determine that a 30° position during the acute phase of severe ischemic stroke is safe. The secondary purpose is to evaluate whether a 30° position in the acute phase improves 90-day outcomes compared to a 0° position (assessed using the modified Rankin Scale). This study is a randomized controlled trial. This means you will be randomly assigned (like a coin toss) to one of the following two groups: Experimental group: within 24 hours of admission, maintain the head and bed elevated at 30°. Control group: within 24 hours of admission, remain completely flat (0°). Interventions and methods: Both head positions are commonly used basic nursing measures in neurological intensive care. Lying flat may help increase blood supply to the brain, while elevating the head of the bed may help reduce cerebral edema and the risk of aspiration. This study aims to scientifically compare which angle is better for your long-term recovery. Procedures: Research nurses will use a special angle ruler to ensure your head position is accurate. During the 24-hour intervention, we need you to maintain the assigned position as much as possible. Considering your comfort and necessary medical care (such as back patting and skin inspection), brief interruptions are allowed (no more than three times for the flat position group, with each interruption less than 30 minutes). Legal Compliance: Head positioning management is a routine nursing procedure. This study only conducted standardization and comparative research on it, and did not involve the use of any experimental drugs or high-risk devices. It has passed ethical review.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
1,508
Raise the head of the bed by 30° and maintain for 24 hours. Use a standardized angle ruler and position cushion to ensure accuracy of the angle, bed head angle (including pillow)
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Score of Modified Rankin Scale
Modified Barthel Index (MBI): is a measure of activities of daily living (ADL), which shows the degree of independence of a patient from any assistance. It is an important method used to evaluate the capacity of participants to conduct 10 different ADLs, considered basic ADLs, thus providing a quantitative estimation of their independence level. The mRS is an ordinal scale that ranges from 0 (no symptoms) to 6 (death).
Time frame: day 90
Patient mortality
Patient mortality within 90 days, used for safety assessment
Time frame: day 90
Score of National Institutes of Health Stroke Scale reduced by ≥4 points
Neurological function improvement
Time frame: 5-7 days
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