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NCT Number: NCT06967285

Prone Positioning in ARDS: Predicting Neurological Complications Via Cerebral Hemodynamics

Prone Positioning in ARDS: Predicting Neurological Complications via Cerebral Hemodynamics

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Key information

Conditions

ARDS (Moderate or Severe) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial People's Hospital,

Chengdu, Sichuan, 610072, China

Location status: Recruiting

Location contact

lingai Pan, PhD

CONTACT

[email protected]

17708130236

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone ventilation

Behavioral

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).

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Incidence rate of delirium

    Time frame: From 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.

  2. Cognitive function

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

lingai Pan, PhD

CONTACT

[email protected]

17708130236

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: PRONEBRAINAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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