Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring

NCT ID: NCT07115459

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-11-15

Brief Summary

This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.

Detailed Description

This study is a prospective, observational, multicenter cohort study conducted in China. It focuses on neurocritical patients with acute brain injury, including large cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury. The study will collect multimodal data from EEG, TCD, and NIRS monitoring within 1-3 days of ICU admission. Machine learning algorithms will be used to develop a model predicting 90-day outcomes, categorized as awake, comatose, or deceased. The study population includes patients aged 18-80 years. Exclusion criteria include pre-existing severe neurological disorders, incomplete monitoring data, or withdrawal during the study period.

Conditions

Acute Brain Injury Coma; Neurocritical Care; Cerebral Infarction; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Severe Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Aged 18-80 years, no gender restrictions.

2. Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis.

3. On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8).

4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.

5. Informed consent signed by the family or legal representative.

Exclusion Criteria

1. Confirmed brain death on admission or imaging showing irreversible brain herniation.

2. Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment.

3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).

4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).

5. Predicted survival time <24 hours after admission, or family members choose to withdraw treatment.

6. Refusal to participate in the study by the patient or their legal representative.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changsha Fourth Hospital

OTHER_GOV

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024070747-2

Identifier Type: -

Identifier Source: org_study_id