Head Position After Endovascular Therapy

NCT ID: NCT06115707

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2025-04-26

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.

Conditions

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Stroke, Acute Endovascular Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The lying flat group

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.

Group Type ACTIVE_COMPARATOR

The lying flat (0°-10°) head position for 72 hours

Intervention Type OTHER

The lying flat (0°-10°) head position for 72 hours after endovascular therapy.

The head elevation group

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.

Group Type EXPERIMENTAL

The The head elevation (30°-40°) position for 72 hours

Intervention Type OTHER

The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.

Interventions

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The lying flat (0°-10°) head position for 72 hours

The lying flat (0°-10°) head position for 72 hours after endovascular therapy.

Intervention Type OTHER

The The head elevation (30°-40°) position for 72 hours

The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Clinical signs consistent with acute ischemic stroke;
2. Age ≥ 18 years old;
3. Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
4. NIHSS score ≥ 8 points before endovascular treatment;
5. ASPECTS score ≤ 7 points before endovascular treatment;
6. Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ;
7. The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
8. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria

1. Pre-stroke mRS score\>1 point;
2. Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
3. Currently in pregnant or lactating or serum beta HCG test is positive on admission;
4. Contraindications to a flat head position;
5. Any terminal illness with life expectancy less than 6 months;
6. Participating in other clinical trials;
7. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
8. Unlikely to be available for 90-day follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhengzhou Yuan

OTHER

Sponsor Role lead

Responsible Party

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Zhengzhou Yuan

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhengzhou Yuan

Role: STUDY_CHAIR

Affiliated Hospital of Southwest Medical University

Yong Jiang

Role: STUDY_CHAIR

Affiliated Hospital of Southwest Medical University

Locations

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Chongqing Banan District People's Hospital

Chongqing, Chongqing Municipality, China

Site Status

Chongqing Bishan District People's Hospital

Chongqing, Chongqing Municipality, China

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Chongqing Ninth People's Hospital

Chongqing, Chongqing Municipality, China

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Yongchuan Hospital Affiliated to Chongqing Medical University

Chongqing, Chongqing Municipality, China

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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Longyan First Hospital

Longyan, Fujian, China

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Dingxi People's Hospital

Dingxi, Gansu, China

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Jiuquan People's Hospital

Jiuquan, Gansu, China

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Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, China

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Lanzhou University First Hospital

Lanzhou, Gansu, China

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

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Tianshui First People's Hospital

Tianshui, Gansu, China

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Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China

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Guangdong Provincial People's Hospital Heyuan Hospital

Heyuan, Guangdong, China

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Baise People's Hospital

Baise City, Guangxi, China

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Nanning Third People's Hospital

Nanning, Guangxi, China

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Qiannan Prefecture People's Hospital

Duyun, Guizhou, China

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Xingyi People's Hospital

Xingyi, Guizhou, China

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The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China

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Jiamusi Central Hospital

Jiamusi, Heilongjiang, China

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Yichun First Hospital

Yichun, Heilongjiang, China

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Anyang People's Hospital

Anyang, Henan, China

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Xihua County People's Hospital

Zhoukou, Henan, China

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Shiyan taihe hospital

Shiyan, Hubei, China

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Ningxiang First People's Hospital

Changsha, Hunan, China

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The First People's Hospital of Chenzhou City

Chenzhou, Hunan, China

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Ganzhou Municipal Hospital

Ganzhou, Jiangxi, China

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Ganzhou People's Hospital

Ganzhou, Jiangxi, China

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Xingguo County People's Hospital

Ganzhou, Jiangxi, China

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Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

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The First Hospital of Jilin University

Changchun, Jilin, China

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Dalian 967 Hospital

Dalian, Liaoning, China

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Ningxia Hui Autonomous Region People's Hospital

Yinchuan, Ningxia, China

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The Fifth People's Hospital of Qinghai Province

Xining, Qinghai, China

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Baoji High tech Hospital

Baoji, Shaanxi, China

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Northwest University Affiliated Hospital

Xi'an, Shaanxi, China

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Xidian Group Hospital

Xi'an, Shaanxi, China

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Xianyang First People's Hospital

Xianyang, Shaanxi, China

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Yulin First Hospital

Yulin, Shaanxi, China

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Rizhao Traditional Chinese Medicine Hospital

Rizhao, Shandong, China

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Shanxi Provincial Hospital

Taiyuan, Shanxi, China

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Chengdu Sixth People's Hospital

Chengdu, Sichuan, China

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Chongzhou People's Hospital

Chengdu, Sichuan, China

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Deyang People's Hospital

Deyang, Sichuan, China

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Guangyuan First People's Hospital

Guangyuan, Sichuan, China

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Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

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Gulin County People's Hospital

Luzhou, Sichuan, China

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Beichuan County People's Hospital

Mianyang, Sichuan, China

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Mianyang 404 Hospital

Mianyang, Sichuan, China

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Mianyang Central Hospital

Mianyang, Sichuan, China

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Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

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Neijiang Second People's Hospital

Neijiang, Sichuan, China

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Suining Central Hospital

Suining, Sichuan, China

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Suining First People's Hospital

Suining, Sichuan, China

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Liangshan First People's Hospital

Xichang, Sichuan, China

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Xichang People's Hospital

Xichang, Sichuan, China

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Ya'an People's Hospital

Ya'an, Sichuan, China

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Yibin Second People's Hospital

Yibin, Sichuan, China

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Fushun County People's Hospital

Zigong, Sichuan, China

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Zigong First People's Hospital

Zigong, Sichuan, China

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Zigong Fourth People's Hospital

Zigong, Sichuan, China

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Zigong Third People's Hospital

Zigong, Sichuan, China

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The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

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The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

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The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

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Qujing First People's Hospital

Qujing, Yunnan, China

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Wenzhou Medical University First Affiliated Hospital

Wenzhou, Zhejiang, China

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Countries

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China

Other Identifiers

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SWMU202305

Identifier Type: -

Identifier Source: org_study_id

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