Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury

Recruiting

• Conditions: Multimodal Monitoring

• Registration Number: NCT06583252
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Age >18 years, 2.Diagnosis of an acute brain injury (ABI) due to TBI, 3.GCS with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to intensive care unit (ICU) or neuro-worsen-ing within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

Exclusion Criteria

1. Have had a major stroke before.
2. Pregnant or likely to become pregnant. 3 In the opinion of the treatment team, the decrease in GCS (Glasgow Coma Scale) score is solely due to intoxication, sedation, or extracranial injury.

4 Participants are unlikely to comply with all study procedures, including follow-up, in the opinion of the investigator.

5. Have an underlying medical condition with a life expectancy of less than 6 months.

6. There are pre-existing contraindications to MRI examination. 7 suffer devastating TBI, either progressing to brain death at the time of recruitment, or the treating medical team does not commit to continuous, comprehensive aggressive treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Score-Extended at 6 months	6 months	Glasgow Outcome Score-Extended at 6 months