Stroke AcuteNCT07507097
Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke
A study testing head position in people with Stroke Acute, run by West China Hospital at 1 site in China.
Trial summary
Stroke is the second leading cause of death and the third leading cause of disability worldwide, with an increasing incidence. Reperfusion therapy after cerebral ischemia is one of the most practical and effective treatments for ischemic stroke globally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- head position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,508 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Meeting the diagnostic criteria for acute ischemic stroke according to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023": ①Acute onset, ②Focal neurological deficits, with a few having global neurological deficits, ③Imaging shows a corresponding lesion or symptoms/signs persist for more than 24 hours, ④Exclusion of non-vascular causes, ⑤Brain CT/MRI excludes cerebral hemorrhage
- Meeting the criteria for severe ischemic stroke patients: severe neurological deficits at admission [for example, National Institutes of Health Stroke Scale (NIHSS) score≥15]
- First-time diagnosed ischemic stroke patients who undergo thrombolysis and/or thrombectomy reperfusion treatment
- Time from onset to randomization within 24 hours
- Informed consent obtained and signed by the patient or their family
Who cannot join
- Known pregnancy or breastfeeding, or positive pregnancy test before randomization
- Expected survival time less than 3 months (such as with malignant tumors, severe cardiopulmonary diseases, etc)
- Already participating in other interventional clinical studies that may affect outcome assessment
- Other situations deemed by the investigator as unsuitable for participation in this study or that may pose significant risks to the patient (such as inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders)
- Presence of brain midline shift or herniation, ventricular mass effect
- Patients with limited head elevation (or patients unable to cooperate with postural intervention due to their condition/recovery needs, etc.)
- Presence of respiratory infection symptoms such as fever, cough, or sputum production at the time of admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
ling feng, Master's degree, 18980602079, fengling216@163.com
About this study
Stroke is the second leading cause of death and the third leading cause of disability worldwide, with an increasing incidence. Reperfusion therapy after cerebral ischemia is one of the most practical and effective treatments for ischemic stroke globally. However, the nursing care and management of hemodynamics during the acute phase after reperfusion therapy for ischemic stroke have always been key and challenging aspects of clinical work. Stable hemodynamic status can prevent hypoperfusion or hyperperfusion of brain tissue, reduce damage to the ischemic core and penumbra areas, and consequently decrease cerebral edema, elevated intracranial pressure, and the associated neurological damage and worsening clinical outcomes.
Head positioning, as a simple, economical, and effective adjunctive treatment for managing patients undergoing reperfusion therapy, has gradually received attention. During the acute phase of stroke, brain tissue is in a state of ischemia and hypoxia. Lying flat may increase blood and oxygen supply to the brain tissue, providing a certain degree of protection, but it may also have some impact on swallowing and lung function. Raising the head of the bed can help venous blood return from the head and may reduce cerebral edema to some extent, but it can also affect perfusion of ischemic brain tissue to a certain degree. In the acute phase after successful reperfusion, it remains a clinical challenge to maintain stable cerebral blood supply (hemodynamic stability) through nursing care. Head positioning (lying flat or elevating the head of the bed) is a simple, economical nursing measure that may affect cerebral blood flow. However, for severely affected stroke patients like you, there is no clear international consensus on whether maintaining a flat position (0°) or elevating the head of the bed 30° within the first 24 hours after treatment is more beneficial for long-term recovery. Previous studies have shown inconsistent results, so more rigorous research is needed to answer this question.
Read more
The primary purpose of this study is to determine that a 30° position during the acute phase of severe ischemic stroke is safe. The secondary purpose is to evaluate whether a 30° position in the acute phase improves 90-day outcomes compared to a 0° position (assessed using the modified Rankin Scale).
This study is a randomized controlled trial. This means you will be randomly assigned (like a coin toss) to one of the following two groups: Experimental group: within 24 hours of admission, maintain the head and bed elevated at 30°. Control group: within 24 hours of admission, remain completely flat (0°). Interventions and methods: Both head positions are commonly used basic nursing measures in neurological intensive care. Lying flat may help increase blood supply to the brain, while elevating the head of the bed may help reduce cerebral edema and the risk of aspiration. This study aims to scientifically compare which angle is better for your long-term recovery. Procedures: Research nurses will use a special angle ruler to ensure your head position is accurate. During the 24-hour intervention, we need you to maintain the assigned position as much as possible. Considering your comfort and necessary medical care (such as back patting and skin inspection), brief interruptions are allowed (no more than three times for the flat position group, with each interruption less than 30 minutes). Legal Compliance: Head positioning management is a routine nursing procedure. This study only conducted standardization and comparative research on it, and did not involve the use of any experimental drugs or high-risk devices. It has passed ethical review.
- Conditions
- Stroke Acute
- Being tested
- head position
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head positionBehavioural
Raise the head of the bed by 30° and maintain for 24 hours. Use a standardized angle ruler and position cushion to ensure accuracy of the angle, bed head angle (including pillow)
| Study group | Role | What they receive |
|---|---|---|
| 0-degree head position | No intervention | Keep the head flat at 0° (completely lying down) for 24 hours. During this period, including eating and using the toilet, you must remain lying flat, but intermittent interruptions due to necessary nursing operations (such as back patting or skin checks) are allowed, not exceeding a total of 3 times, with each interruption ≤30 minutes. |
| 30-degree head position | Experimental | Raise the head of the bed by 30° and maintain for 24 hours. Use a standardized angle ruler and position cushion to ensure accuracy of the angle, bed head angle (including pillow) Receives: Behavioral: head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Modified Rankin Scale
Modified Barthel Index (MBI): is a measure of activities of daily living (ADL), which shows the degree of independence of a patient from any assistance. It is an important method used to evaluate the capacity of participants to conduct 10 different ADLs, considered basic ADLs, thus providing a quantitative estimation of their independence level. The mRS is an ordinal scale that ranges from 0 (no symptoms) to 6 (death).
Measured: day 90
Patient mortality
Patient mortality within 90 days, used for safety assessment
Measured: day 90
Secondary outcomes (1)
Score of National Institutes of Health Stroke Scale reduced by ≥4 points
Neurological function improvement
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Feng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507097
- Sponsor's protocol ID
- WestChinaH-neuro
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07507097
- Acronym / sponsor ID
- WestChinaH-neuro
- Conditions
- Stroke Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the second leading cause of death and the third leading cause of disability worldwide, with an increasing incidence. Reperfusion therapy after cerebral ischemia is one of the most practical and effective treatments for ischemic stroke globally. However, the nursing care and management of hemodynamics during the acute phase after reperfusion therapy for ischemic stroke have always been key and challenging aspects of clinical work. Stable hemodynamic status can prevent hypoperfusion or hyperperfusion of brain tissue, reduce damage to the ischemic core and penumbra areas, and consequently decrease cerebral edema, elevated intracranial pressure, and the associated neurological damage and worsening clinical outcomes.
Head positioning, as a simple, economical, and effective adjunctive treatment for managing patients undergoing reperfusion therapy, has gradually received attention. During the acute phase of stroke, brain tissue is in a state of ischemia and hypoxia. Lying flat may increase blood and oxygen supply to the brain tissue, providing a certain degree of protection, but it may also have some impact on swallowing and lung function. Raising the head of the bed can help venous blood return from the head and may reduce cerebral edema to some extent, but it can also affect perfusion of ischemic brain tissue to a certain degree. In the acute phase after successful reperfusion, it remains a clinical challenge to maintain stable cerebral blood supply (hemodynamic stability) through nursing care. Head positioning (lying flat or elevating the head of the bed) is a simple, economical nursing measure that may affect cerebral blood flow. However, for severely affected stroke patients like you, there is no clear international consensus on whether maintaining a flat position (0°) or elevating the head of the bed 30° within the first 24 hours after treatment is more beneficial for long-term recovery. Previous studies have shown inconsistent results, so more rigorous research is needed to answer this question.
The primary purpose of this study is to determine that a 30° position during the acute phase of severe ischemic stroke is safe. The secondary purpose is to evaluate whether a 30° position in the acute phase improves 90-day outcomes compared to a 0° position (assessed using the modified Rankin Scale).
This study is a randomized controlled trial. This means you will be randomly assigned (like a coin toss) to one of the following two groups: Experimental group: within 24 hours of admission, maintain the head and bed elevated at 30°. Control group: within 24 hours of admission, remain completely flat (0°). Interventions and methods: Both head positions are commonly used basic nursing measures in neurological intensive care. Lying flat may help increase blood supply to the brain, while elevating the head of the bed may help reduce cerebral edema and the risk of aspiration. This study aims to scientifically compare which angle is better for your long-term recovery. Procedures: Research nurses will use a special angle ruler to ensure your head position is accurate. During the 24-hour intervention, we need you to maintain the assigned position as much as possible. Considering your comfort and necessary medical care (such as back patting and skin inspection), brief interruptions are allowed (no more than three times for the flat position group, with each interruption less than 30 minutes). Legal Compliance: Head positioning management is a routine nursing procedure. This study only conducted standardization and comparative research on it, and did not involve the use of any experimental drugs or high-risk devices. It has passed ethical review.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-degree head position | No intervention | –Keep the head flat at 0° (completely lying down) for 24 hours. During this period, including eating and using the toilet, you must remain lying flat, but intermittent interruptions due to necessary nursing operations (such as back patting or skin checks) are allowed, not exceeding a total of 3 times, with each interruption ≤30 minutes. |
| 30-degree head position | Experimental | Behavioral: head positionRaise the head of the bed by 30° and maintain for 24 hours. Use a standardized angle ruler and position cushion to ensure accuracy of the angle, bed head angle (including pillow) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Meeting the diagnostic criteria for acute ischemic stroke according to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023": ①Acute onset, ②Focal neurological deficits, with a few having global neurological deficits, ③Imaging shows a corresponding lesion or symptoms/signs persist for more than 24 hours, ④Exclusion of non-vascular causes, ⑤Brain CT/MRI excludes cerebral hemorrhage
- Meeting the criteria for severe ischemic stroke patients: severe neurological deficits at admission [for example, National Institutes of Health Stroke Scale (NIHSS) score≥15]
- First-time diagnosed ischemic stroke patients who undergo thrombolysis and/or thrombectomy reperfusion treatment
- Time from onset to randomization within 24 hours
Key exclusion criteria (7 listed)
- Known pregnancy or breastfeeding, or positive pregnancy test before randomization
- Expected survival time less than 3 months (such as with malignant tumors, severe cardiopulmonary diseases, etc)
- Already participating in other interventional clinical studies that may affect outcome assessment
- Other situations deemed by the investigator as unsuitable for participation in this study or that may pose significant risks to the patient (such as inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders)
- Presence of brain midline shift or herniation, ventricular mass effect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head positionRaise the head of the bed by 30° and maintain for 24 hours. Use a standardized angle ruler and position cushion to ensure accuracy of the angle, bed head angle (including pillow) | Behavioural | 30-degree head position |
Primary outcome
Score of Modified Rankin Scale
Time frame: day 90
Modified Barthel Index (MBI): is a measure of activities of daily living (ADL), which shows the degree of independence of a patient from any assistance. It is an important method used to evaluate the capacity of participants to conduct 10 different ADLs, considered basic ADLs, thus providing a quantitative estimation of their independence level. The mRS is an ordinal scale that ranges from 0 (no symptoms) to 6 (death).
Patient mortality
Time frame: day 90
Patient mortality within 90 days, used for safety assessment
1 secondary outcome
Score of National Institutes of Health Stroke Scale reduced by ≥4 points
Time frame: 5-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head position in people with Stroke Acute, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ling feng, Master's degree (08618980602079, fengling216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Modified Rankin Scale (time frame: day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.