Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke

Обзор

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.

Вмешательства

• Поведенческое head position
  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)

Первичные конечные точки

• Score of Modified Rankin Scale [Срок оценки: day 90]
• Patient mortality [Срок оценки: day 90]

Вторичные конечные точки (1)

• Score of National Institutes of Health Stroke Scale reduced by ≥4 points [Срок оценки: 5-7 days]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Meeting the diagnostic criteria for acute ischemic stroke according to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023": ①Acute onset, ②Focal neurological deficits, with a few having global neurological deficits, ③Imaging shows a corresponding lesion or symptoms/signs persist for more than 24 hours, ④Exclusion of non-vascular causes, ⑤Brain CT/MRI excludes cerebral hemorrhage
• Meeting the criteria for severe ischemic stroke patients: severe neurological deficits at admission \[for example, National Institutes of Health Stroke Scale (NIHSS) score≥15\]
• First-time diagnosed ischemic stroke patients who undergo thrombolysis and/or thrombectomy reperfusion treatment
• Time from onset to randomization within 24 hours
• Informed consent obtained and signed by the patient or their family

Критерии исключения

• Known pregnancy or breastfeeding, or positive pregnancy test before randomization
• Expected survival time less than 3 months (such as with malignant tumors, severe cardiopulmonary diseases, etc)
• Already participating in other interventional clinical studies that may affect outcome assessment
• Other situations deemed by the investigator as unsuitable for participation in this study or that may pose significant risks to the patient (such as inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders)
• Presence of brain midline shift or herniation, ventricular mass effect
• Patients with limited head elevation (or patients unable to cooperate with postural intervention due to their condition/recovery needs, etc.)
• Presence of respiratory infection symptoms such as fever, cough, or sputum production at the time of admission

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT07507097 · WestChinaH-neuro

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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