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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
1,368
The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.
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).
Time frame: 90 days
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
Time frame: 90 days
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
functional independence
Time frame: 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
Time frame: 90 days
Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)
Health-related quality of life
Time frame: 90 days
Mortality within 90 days
evaluate death rate of the two treatment groups
Time frame: 90 days
severe adverse events
evaluate complications and any adverse events
Time frame: within 90 days
Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)
evaluate intracranial hemorrhage
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Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Bishan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Ninth People's Hospital
Chongqing, Chongqing Municipality, China
Yongchuan Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
Dingxi People's Hospital
Dingxi, Gansu, China
Jiuquan People's Hospital
Jiuquan, Gansu, China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
...and 57 more locations
Time frame: within 72 hours after randomized
Any type of intracerebral hemorrhage (Heidelberg Criteria)
evaluate intracranial hemorrhage
Time frame: within 72 hours after randomized
Brain edema
evaluate brain edema
Time frame: within 72 hours after randomized
Malignant Brain Edema
evaluate brain edema
Time frame: within 72 hours after randomized
Incidence of pulmonary infections
evaluate pulmonary infections
Time frame: within 72 hours after randomized
Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d
neurological changes.
Time frame: at 5~7 days after randomization