CClinicalTrials.gg
CompletedNCT06115707HeadSOARUpdated Nov 28, 2025

Head Position After Endovascular Therapy

An interventional study of The lying flat (0°-10°) head position for 72 hours and The The head elevation (30°-40°) position for 72 hours in Stroke, Acute and Endovascular Therapy, sponsored by Zhengzhou Yuan. Completed at 67 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Zhengzhou Yuan · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,368
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke, Acute
  • Endovascular Therapy

Browse trials for

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 1,368 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Zhengzhou Yuan is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,368 participants (actual)

Study arms

  • 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

  • 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

Interventions

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

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

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

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

    functional independence

    Time frame: Within 90 days90 days

  3. 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

  4. Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)

    Health-related quality of life

    Time frame: 90 days

  5. Mortality within 90 days

    evaluate death rate of the two treatment groups

    Time frame: 90 days

  6. severe adverse events

    evaluate complications and any adverse events

    Time frame: within 90 days

  7. Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)

    evaluate intracranial hemorrhage

    Time frame: within 72 hours after randomized

  8. Any type of intracerebral hemorrhage (Heidelberg Criteria)

    evaluate intracranial hemorrhage

    Time frame: within 72 hours after randomized

  9. Brain edema

    evaluate brain edema

    Time frame: within 72 hours after randomized

  10. Malignant Brain Edema

    evaluate brain edema

    Time frame: within 72 hours after randomized

  11. Incidence of pulmonary infections

    evaluate pulmonary infections

    Time frame: within 72 hours after randomized

  12. 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

07

Study locations

67 sites
  • 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 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06115707
Lead sponsor
Zhengzhou Yuan
Responsible party
Zhengzhou Yuan (MD, The Affiliated Hospital Of Southwest Medical University) — Sponsor-investigator
First posted
Nov 3, 2023
Start date
Nov 13, 2023
Primary completion
Apr 26, 2025
Completion
Apr 26, 2025
Last update
Nov 28, 2025

Study contacts

Zhengzhou Yuan
study chair · Affiliated Hospital of Southwest Medical University
Yong Jiang
study chair · Affiliated Hospital of Southwest Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion