Prone Positioning in ARDS: Predicting Neurological Complications Via Cerebral Hemodynamics

NCT06967285 | Recruiting

• 1 other identifier: KY2025PD21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Prone Positioning in ARDS: Predicting Neurological Complications via Cerebral Hemodynamics

Conditions

ARDS (Moderate or Severe)

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From enrollment to 2 weeks after the end of treatment.

Secondary Outcomes (2)

• Incidence rate of delirium

  From enrollment to 2 weeks after the end of treatment.

• Cognitive function

  From enrollment to 2 weeks after the end of treatment.

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Moderate to Severe ARDS Expected to Undergo Mechanical Ventilation for Over 48 Hours

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital,

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• lingai Pan, PhD

  Sichuan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

lingai Pan, PhD

CONTACT

17708130236; panlingai2004@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: May 13, 2025
• Study Start: March 19, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)