Head Position After Endovascular Therapy

Study Overview
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Brief Summary
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The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

Detailed Description
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The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment. The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

Official Title
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Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial

Conditions
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Stroke, Acute, Endovascular Therapy

Intervention / Treatment
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* Other: The lying flat (0°) head position for 72 hours
* Other: The The head elevation (30°) position for 72 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs consistent with acute ischemic stroke; Age ≥ 18 years old; Proved anterior circulation intracranial large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem); NIHSS score ≥ 8 points before endovascular treatment; ASPECTS score ≤ 7 points before endovascular treatment; Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ； The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time); Written informed consent is obtained from patients and/or their legal representatives. Exclusion Criteria: Pre-stroke mRS score>1 point; Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); Currently in pregnant or lactating or serum beta HCG test is positive on admission; Immediate after endovascular treatment, CT indicates brain hemorrhage with significant mass effect; Contraindications to a flat head position; Any terminal illness with life expectancy less than 6 months; Participating in other clinical trials; Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; Unlikely to be available for 90-day follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The lying flat group<br>Patients in lying flat intervention to be nursed lying flat (0°) after endovascular therapy is made and to remain in this position for 72 hours. | Other: The lying flat (0°) head position for 72 hours<br>* The lying flat (0°) head position for 72 hours after endovascular therapy.<br>|
| Experimental: The head elevation group<br>Patients in the sitting up intervention should be nursed with their head elevated (30°) by raising the head of the bed (or using extra pillows or wedges) after undergoing endovascular therapy, and to remain in this position for 72 hours. | Other: The The head elevation (30°) position for 72 hours<br>* The head elevoatin (30°) position for 72 hours after endovascular therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale score (mRS) | disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) | excellent outcome | 90 days | 
| Proportion of patients functionally independent (mRS score 0 to 2) at 90 days | functional independence | Within 90 days90 days | 
| Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) | ambulatory or bodily needs-capable or better | 90 days | 
| Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) | Health-related quality of life | 90 days | 
| Mortality within 90 days | evaluate death rate of the two treatment groups | 90 days | 
| severe adverse events | evaluate complications and any adverse events | within 90 days | 
| Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria) | evaluate intracranial hemorrhage | within 72 hours after randomized | 
| Any type of intracerebral hemorrhage (Heidelberg Criteria) | evaluate intracranial hemorrhage | within 72 hours after randomized | 
| Brain edema | evaluate brain edema | within 72 hours after randomized | 
| Malignant Brain Edema | evaluate brain edema | within 72 hours after randomized | 
| Incidence of pulmonary infections | evaluate pulmonary infections | within 72 hours after randomized | 
| Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5 7d | neurological changes. | at 5 7 days after randomization |