Skip to content

Prone Positioning in ARDS: Predicting Neurological Complications Via Cerebral Hemodynamics

Changes in Cerebral Blood Flow Before and After Prone Position in Patients With ARDS Predict the Occurrence of Neurological Complications

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06967285
Acronym
PRONEBRAINAR
Enrollment
50
Registered
2025-05-13
Start date
2025-03-19
Completion date
2026-04-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS (Moderate or Severe)

Brief summary

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.

Interventions

BEHAVIORALProne ventilation

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).

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Neuroimaging StudiesFrom 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 DetectionFrom 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.

Secondary

MeasureTime frameDescription
Incidence rate of deliriumFrom enrollment to 2 weeks after the end of treatment.Assessment using the Confusion Assessment Method for the Intensive Care Unit(CAM-ICU)was conducted before and after prone position therapy in patients.
Cognitive functionFrom enrollment to 2 weeks after the end of treatment.Assessment using the Mini-Mental State Examination(MMSE)was conducted before and after prone position therapy in patients.

Countries

China

Contacts

Primary Contactlingai Pan, PhD
panlingai2004@163.com17708130236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026