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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The lying flat group | Active Comparator | Patients in lying flat intervention to be nursed lying flat (0°-10°) after endovascular therapy is made and to remain in this position for 72 hours. |
|
| The head elevation group | Experimental | Patients in the sitting up intervention should be nursed with their head elevated (30°-40°) 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The lying flat (0°-10°) head position for 72 hours | Other | The lying flat (0°-10°) head position for 72 hours after endovascular therapy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhengzhou Yuan | Affiliated Hospital of Southwest Medical University | Study Chair |
| Yong Jiang | Affiliated Hospital of Southwest Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Banan District People's Hospital | Chongqing | Chongqing Municipality | China | |||
| Chongqing Bishan District People's Hospital |
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| The The head elevation (30°-40°) position for 72 hours | Other | The head elevoatin (30°-40°) position for 72 hours after endovascular therapy. |
|
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 EuroQol-visual analogue scales (EQ-VAS) | 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 |
| 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 | 364099 | 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 |
| Lanzhou University Second Hospital | Lanzhou | Gansu | China |
| Tianshui First People's Hospital | Tianshui | Gansu | China |
| Zhujiang Hospital of Southern Medical University | Guanzhou | Guangdong | China |
| Guangdong Provincial People's Hospital Heyuan Hospital | Heyuan | Guangdong | China |
| Baise People's Hospital | Baise City | Guangxi | China |
| Nanning Third People's Hospital | Nanning | Guangxi | China |
| Qiannan Prefecture People's Hospital | Duyun | Guizhou | China |
| Xingyi People's Hospital | Xingyi | Guizhou | China |
| The First Affiliated Hospital of Hainan Medical College | Haikou | Hainan | China |
| Jiamusi Central Hospital | Jiamusi | Heilongjiang | China |
| Yichun First Hospital | Yichun | Heilongjiang | China |
| Anyang People's Hospital | Anyang | Henan | China |
| Xihua County People's Hospital | Zhoukou | Henan | China |
| Shiyan taihe hospital | Shiyan | Hubei | China |
| Ningxiang First People's Hospital | Changsha | Hunan | China |
| The First People's Hospital of Chenzhou City | Chenzhou | Hunan | China |
| Ganzhou Municipal Hospital | Ganzhou | Jiangxi | China |
| Ganzhou People's Hospital | Ganzhou | Jiangxi | China |
| Xingguo County People's Hospital | Ganzhou | Jiangxi | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Dalian 967 Hospital | Dalian | Liaoning | China |
| Ningxia Hui Autonomous Region People's Hospital | Yinchuan | Ningxia | China |
| The Fifth People's Hospital of Qinghai Province | Xining | Qinghai | China |
| Baoji High tech Hospital | Baoji | Shaanxi | China |
| Northwest University Affiliated Hospital | Xi'an | Shaanxi | China |
| Xidian Group Hospital | Xi'an | Shaanxi | China |
| Xianyang First People's Hospital | Xianyang | Shaanxi | China |
| Yulin First Hospital | Yulin | Shaanxi | China |
| Rizhao Traditional Chinese Medicine Hospital | Rizhao | Shandong | China |
| Shanxi Provincial Hospital | Taiyuan | Shanxi | China |
| Chengdu Sixth People's Hospital | Chengdu | Sichuan | China |
| Chongzhou People's Hospital | Chengdu | Sichuan | China |
| Deyang People's Hospital | Deyang | Sichuan | China |
| Guangyuan First People's Hospital | Guangyuan | Sichuan | China |
| Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
| Gulin County People's Hospital | Luzhou | Sichuan | China |
| Beichuan County People's Hospital | Mianyang | Sichuan | China |
| Mianyang 404 Hospital | Mianyang | Sichuan | China |
| Mianyang Central Hospital | Mianyang | Sichuan | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | China |
| Neijiang Second People's Hospital | Neijiang | Sichuan | China |
| Suining Central Hospital | Suining | Sichuan | China |
| Suining First People's Hospital | Suining | Sichuan | China |
| Liangshan First People's Hospital | Xichang | Sichuan | China |
| Xichang People's Hospital | Xichang | Sichuan | China |
| Ya'an People's Hospital | Ya'an | Sichuan | China |
| Yibin Second People's Hospital | Yibin | Sichuan | China |
| Fushun County People's Hospital | Zigong | Sichuan | China |
| Zigong First People's Hospital | Zigong | Sichuan | China |
| Zigong Fourth People's Hospital | Zigong | Sichuan | China |
| Zigong Third People's Hospital | Zigong | Sichuan | China |
| The Seventh Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Qujing First People's Hospital | Qujing | Yunnan | China |
| Wenzhou Medical University First Affiliated Hospital | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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