Head Position After Endovascular Therapy (HeadSOAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute; Endovascular Therapy
• Intervention / Treatment: Other: The lying flat (0°-10°) head position for 72 hours; Other: The The head elevation (30°-40°) position for 72 hours

Detailed Description

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
• Enrollment (Actual): 1368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • 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
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
    • Longyan, Fujian, China, 364099
      • Longyan First Hospital
  • Gansu
    • Dingxi, Gansu, China
      • Dingxi People's Hospital
    • Jiuquan, Gansu, China
      • Jiuquan People's Hospital
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
    • Lanzhou, Gansu, China
      • Gansu Provincial Hospital of Traditional Chinese Medicine
    • Lanzhou, Gansu, China
      • Lanzhou University First Hospital
    • Tianshui, Gansu, China
      • Tianshui First People's Hospital
  • Guangdong
    • Guanzhou, Guangdong, China
      • Zhujiang Hospital of Southern Medical University
    • Heyuan, Guangdong, China
      • Guangdong Provincial People's Hospital Heyuan Hospital
  • Guangxi
    • Baise City, Guangxi, China
      • Baise People's Hospital
    • Nanning, Guangxi, China
      • Nanning Third People's Hospital
  • Guizhou
    • Duyun, Guizhou, China
      • Qiannan Prefecture People's Hospital
    • Xingyi, Guizhou, China
      • Xingyi People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • The First Affiliated Hospital Of Hainan Medical College
  • Heilongjiang
    • Jiamusi, Heilongjiang, China
      • Jiamusi Central Hospital
    • Yichun, Heilongjiang, China
      • Yichun First Hospital
  • Henan
    • Anyang, Henan, China
      • Anyang People's Hospital
    • Zhoukou, Henan, China
      • Xihua County People's Hospital
  • Hubei
    • Shiyan, Hubei, China
      • Shiyan Taihe Hospital
  • Hunan
    • Changsha, Hunan, China
      • Ningxiang First People's Hospital
    • Chenzhou, Hunan, China
      • The First People's Hospital of Chenzhou City
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Ganzhou Municipal Hospital
    • Ganzhou, Jiangxi, China
      • Xingguo County People's Hospital
    • Ganzhou, Jiangxi, China
      • Ganzhou People's Hospital
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • Dalian 967 Hospital
  • Ningxia
    • Yinchuan, Ningxia, China
      • Ningxia Hui Autonomous Region People's Hospital
  • Qinghai
    • Xining, Qinghai, China
      • The Fifth People's Hospital of Qinghai Province
  • Shaanxi
    • Baoji, Shaanxi, China
      • Baoji High tech Hospital
    • Xi'an, Shaanxi, China
      • Northwest University Affiliated Hospital
    • Xi'an, Shaanxi, China
      • Xidian group hospital
    • Xianyang, Shaanxi, China
      • Xianyang First People's Hospital
    • Yulin, Shaanxi, China
      • Yulin First Hospital
  • Shandong
    • Rizhao, Shandong, China
      • Rizhao traditional Chinese medicine hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Provincial Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Chongzhou People's Hospital
    • Chengdu, Sichuan, China
      • Chengdu Sixth People's Hospital
    • Deyang, Sichuan, China
      • Deyang People's Hospital
    • Guangyuan, Sichuan, China
      • Guangyuan First People's Hospital
    • Luzhou, Sichuan, China, 646000
      • Affiliated Hospital of Southwest Medical University
    • Luzhou, Sichuan, China
      • Gulin County People's Hospital
    • Mianyang, Sichuan, China
      • Mianyang 404 Hospital
    • Mianyang, Sichuan, China
      • Mianyang Central Hospital
    • Mianyang, Sichuan, China
      • Beichuan County People's Hospital
    • Nanchong, Sichuan, China
      • Affiliated Hospital of North Sichuan Medical College
    • Neijiang, Sichuan, China
      • Neijiang Second People's Hospital
    • Suining, Sichuan, China
      • Suining Central Hospital
    • Suining, Sichuan, China
      • Suining First People's Hospital
    • Xichang, Sichuan, China
      • Liangshan First People's Hospital
    • Xichang, Sichuan, China
      • Xichang People's Hospital
    • Ya'an, Sichuan, China
      • Ya'an People's Hospital
    • Yibin, Sichuan, China
      • Yibin Second People's Hospital
    • Zigong, Sichuan, China
      • Zigong First People's Hospital
    • Zigong, Sichuan, China
      • Zigong Third People's Hospital
    • Zigong, Sichuan, China
      • Zigong Fourth People's hospital
    • Zigong, Sichuan, China
      • Fushun County People's Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • The Seventh Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • The Second Affiliated Hospital of Kunming Medical University
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University
    • Qujing, Yunnan, China
      • Qujing First People's Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Wenzhou Medical University First Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: The lying flat (0°-10°) head position for 72 hours; The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
Experimental: 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.	Other: The The head elevation (30°-40°) position for 72 hours; The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.

What is the study measuring?

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
Mortality within 90 days	evaluate death rate of the two treatment groups	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	90 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
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days	functional independence	Within 90 days90 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
Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)	Health-related quality of life	90 days

Collaborators and Investigators

• Sponsor: Zhengzhou Yuan
• Investigators: Study Chair: Zhengzhou Yuan, Affiliated Hospital of Southwest Medical University; Study Chair: Yong Jiang, Affiliated Hospital of Southwest Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): April 26, 2025
• Study Completion (Actual): April 26, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Patient Positioning
• Other Study ID Numbers: SWMU202305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No