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RecruitingNCT06583252Updated Sep 3, 2024

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

An observational study in Multimodal Monitoring, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Multimodal Monitoring
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Traumatic brain injury

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

-

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.

  1. Have an underlying medical condition with a life expectancy of less than 6 months.
  1. 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Devicemultimodal monitoring cluster management

    All patients will be monitored for baseline TCD at admission and at least once a day during treatment to assess changes in cerebral blood flow dynamics. Brain Oxygen Monitoring, Equipment \& Frequency: Continuous monitoring of partial pressure of oxygen (PbtO2) in brain tissue using near-infrared spectroscopy (NIRS). qEEG monitoring,Frequency and timing of monitoring. Baseline monitoring: All patients will undergo a baseline qEEG test at the time of admission. Continuous monitoring: In the ICU, for critically ill patients, qEEG will be performed continuously to monitor changes in EEG activity in real time. Monitoring brain activity: qEEG is able to detect subtle changes in brain waves that can be used to assess brain functional status, such as EEG quiescence, abnormal electrical discharges (e.g., epileptiform activity), etc. Abnormal parameters: focus on abnormal rhythms (e.g., high-amplitude slow-wave activity), acute asymmetric activity, and epileptiform discharge.

06

What researchers measure

Primary outcomes

  1. Glasgow Outcome Score-Extended at 6 months

    Glasgow Outcome Score-Extended at 6 months

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Xiangya Hospital
    Changsha, Hunan 410008, China
    • Le Zhang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06583252
Lead sponsor
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Jun 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 3, 2024

Study contacts

Qiaoling Tang
Contact
228111051@csu.edu.cn
18867408758

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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