ARDS (Moderate or Severe)PRONEBRAINARNCT06967285
Prone Positioning in ARDS: Predicting Neurological Complications Via Cerebral Hemodynamics
An observational study of ARDS (Moderate or Severe), run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
Prone Positioning in ARDS: Predicting Neurological Complications via Cerebral Hemodynamics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Moderate or Severe)
- What is being tested?
- Prone ventilation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 1 Apr 2026
- Phase
- Observational
- 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
Study population: Patients with Moderate to Severe ARDS Expected to Undergo Mechanical Ventilation for Over 48 Hours
Who may be able to join
- Age≥18 years
- Meet the diagnostic criteria for ARDS(Acute Respiratory Distress Syndrome),with PaO₂/FiO₂<150 mmHg,and requiring prone ventilation
- Expected duration of mechanical ventilation>48 hours
- Written informed consent obtained
Who cannot join
- Presence of contraindications to prone positioning(e.g.,head and neck injuries,spinal instability,severe intracranial hypertension)
- Severe neurological diseases(e.g.,cerebral hemorrhage,cerebral infarction,intracranial space-occupying lesions)that may affect the monitoring of cerebral hemodynamics
- Life-threatening ARDS
- Patients who are unable to undergo neurological assessment
- Poor image quality or absence of images
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, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital,
Chengdu, Sichuan, 610072
lingai Pan, PhD, 17708130236, panlingai2004@163.com
About this study
Official title: Changes in Cerebral Blood Flow Before and After Prone Position in Patients With ARDS Predict the Occurrence of Neurological Complications
Prone Positioning in ARDS: Predicting Neurological Complications via Cerebral Hemodynamics
Read the detailed description
Collecting Medical Records, Demographic Characteristics, and Clinical Data of Moderate to Severe ARDS Patients Requiring Prone Positioning Treatment at Chengdu Pixdu District People's Hospital, Sichuan Provincial People's Hospital, The Fourth People's Hospital of Chengdu, and Chengdu Shuangliu District First People's Hospital from March 2025 to March 2026.
- Conditions
- ARDS (Moderate or Severe)
- Being tested
- Prone ventilation
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone ventilationBehavioural
Cerebral Blood Flow Monitoring Before and After Prone Ventilation in Patients with ARDS.Cerebral blood flow,intracranial pressure,and systemic hemodynamic monitoring were performed at the following time points:before prone positioning(T0),1 hour after prone ventilation(T1),12 hours after prone ventilation(T2),1 hour after returning to the supine position(T3),and 7 days after returning to the supine position(T4).
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging Studies
Cranial CT or MRI Scans Conducted Before and After Prone Positioning to Detect New-Onset Neurological Complications Such as Cerebral Edema, Intracranial Hemorrhage, and Cerebral Infarction
Measured: From enrollment to 2 weeks after the end of treatment.
Biomarker Detection
Blood samples were collected for NSE(Neuron-specific Enolase)and IL-6(Interleukin-6)before and after prone positioning.
Measured: From enrollment to 2 weeks after the end of treatment.
Secondary outcomes (2)
Incidence rate of delirium
Assessment using the Confusion Assessment Method for the Intensive Care Unit(CAM-ICU)was conducted before and after prone position therapy in patients.
Measured: From enrollment to 2 weeks after the end of treatment.
Cognitive function
Assessment using the Mini-Mental State Examination(MMSE)was conducted before and after prone position therapy in patients.
Measured: From enrollment to 2 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start19 Mar 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
- Investigators
- lingai Pan, PhD, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967285
- Sponsor's protocol ID
- KY2025PD21
- Acronym
- PRONEBRAINAR
- Status last verified
- May 2025
- First submitted
- 22 Mar 2025
- Last updated
- 13 May 2025
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Blood Flow Before and After Prone Position in Patients With ARDS Predict the Occurrence of Neurological Complications
- ClinicalTrials.gov ID
- NCT06967285
- Acronym / sponsor ID
- PRONEBRAINAR / KY2025PD21
- Conditions
- ARDS (Moderate or Severe)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 May 2025 (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.
Prone Positioning in ARDS: Predicting Neurological Complications via Cerebral Hemodynamics
Detailed description
Collecting Medical Records, Demographic Characteristics, and Clinical Data of Moderate to Severe ARDS Patients Requiring Prone Positioning Treatment at Chengdu Pixdu District People's Hospital, Sichuan Provincial People's Hospital, The Fourth People's Hospital of Chengdu, and Chengdu Shuangliu District First People's Hospital from March 2025 to March 2026.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Moderate to Severe ARDS Expected to Undergo Mechanical Ventilation for Over 48 Hours
Key inclusion criteria (4 listed)
- Age≥18 years
- Meet the diagnostic criteria for ARDS(Acute Respiratory Distress Syndrome),with PaO₂/FiO₂<150 mmHg,and requiring prone ventilation
- Expected duration of mechanical ventilation>48 hours
- Written informed consent obtained
Key exclusion criteria (5 listed)
- Presence of contraindications to prone positioning(e.g.,head and neck injuries,spinal instability,severe intracranial hypertension)
- Severe neurological diseases(e.g.,cerebral hemorrhage,cerebral infarction,intracranial space-occupying lesions)that may affect the monitoring of cerebral hemodynamics
- Life-threatening ARDS
- Patients who are unable to undergo neurological assessment
- Poor image quality or absence of images
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 |
|---|---|---|
| Prone ventilationCerebral Blood Flow Monitoring Before and After Prone Ventilation in Patients with ARDS.Cerebral blood flow,intracranial pressure,and systemic hemodynamic monitoring were performed at the following time points:before prone positioning(T0),1 hour after prone ventilation(T1),12 hours after prone ventilation(T2),1 hour after returning to the supine position(T3),and 7 days after returning to the supine position(T4). | Behavioural | – |
Primary outcome
Neuroimaging Studies
Time frame: From enrollment to 2 weeks after the end of treatment.
Cranial CT or MRI Scans Conducted Before and After Prone Positioning to Detect New-Onset Neurological Complications Such as Cerebral Edema, Intracranial Hemorrhage, and Cerebral Infarction
Biomarker Detection
Time frame: From enrollment to 2 weeks after the end of treatment.
Blood samples were collected for NSE(Neuron-specific Enolase)and IL-6(Interleukin-6)before and after prone positioning.
2 secondary outcomes
Incidence rate of delirium
Time frame: From enrollment to 2 weeks after the end of treatment.
Cognitive function
Time frame: From enrollment to 2 weeks after the end of treatment.
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 13 May 2025.
- 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.
lingai Pan, PhD study chair
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Moderate or Severe), run by Sichuan Provincial People's 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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 lingai Pan, PhD (17708130236, panlingai2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroimaging Studies (time frame: From enrollment to 2 weeks after the end of treatment.). 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 13 May 2025.