Monitoring methods for patients with severe traumatic brain injury
Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury
This study is testing if using different monitoring methods together can help doctors provide better care for patients with severe traumatic brain injuries in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06583252 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of multimodal monitoring cluster management for patients suffering from severe traumatic brain injury (TBI). It aims to provide a comprehensive assessment of TBI severity by integrating various monitoring techniques, which may lead to more individualized treatment strategies. The study will evaluate the effectiveness of this approach in improving patient outcomes in the intensive care setting. Although further research is needed, multimodal monitoring is recognized as a valuable clinical decision support tool in neuroscience intensive care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with acute brain injury due to TBI and exhibiting specific Glasgow Coma Scale scores upon ICU admission.
Not a fit: Patients with major strokes prior to the study, those who are pregnant, or individuals whose decreased GCS is solely due to intoxication or other non-TBI related issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment strategies and outcomes for patients with severe traumatic brain injury.
How similar studies have performed: While multimodal monitoring is recognized as an important tool, further studies are needed to confirm its efficacy, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Changsha, Hunan
- Xiangya Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Qiaoling Tang
- Email: 228111051@csu.edu.cn
- Phone: 18867408758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.