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A proof of concept study of BIS in predicting prognosis of acute severe brain injury and chronic disorders of consciousness

A proof of concept study of BIS in predicting prognosis of acute severe brain injury and chronic disorders of consciousness

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100051132
Enrollment
Unknown
Registered
2021-09-14
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe brain injury

Interventions

group of patients with acute severe craniocerebral injury/patients with chronic disorders of consciousness:None

Sponsors

Fujian Provincial Hospital South Branch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The inclusion criteria for the BIS assessment of the degree of coma and prognosis in patients with acute severe brain injury are as follows: (1) Acute brain injury (brain trauma, cerebral hemorrhage, cerebral infarction, cardiopulmonary resuscitation, etc.), the patient is unconscious, and the GCS score is less than or equal to 8 points; (2) Onset time=24 hours before BIS monitoring; (5) Obtain the informed consent of the patient's family (or guardian); (6) Those who have undergone invasive craniocerebral surgery and meet the above inclusion criteria also meet the study requirements. 2. The inclusion criteria for BIS to assess the degree of coma and prognosis in patients with chronic disturbance of consciousness are as follows: (1) Acute brain injury caused by various causes (trauma, hemorrhage, cerebral infarction, after cardiopulmonary resuscitation, etc.), after active treatment, patients who are still awake 28 days after onset (prolonged coma, vegetative state, minimally conscious state); (2) 28d-3 months of onset; (3) Aged 18-70 years; (4) Stop sedatives and analgesics for >=24 hours; (5) Obtain the informed consent of the patient's family (or guardian); (6) If there is hydrocephalus, the hydrocephalus should be treated with ventriculo-peritoneal shunt surgery.

Exclusion criteria

Exclusion criteria: 1. BIS to assess the degree of coma and prognosis in patients with acute severe brain injury. The exclusion criteria are as follows: (1) Obvious cognitive impairment and severe stroke sequelae affect BIS monitoring before the assessment; (2) Severe acidosis, endocrine disorders, electrolyte disorders, hypothermia, hyperthermia, etc. affect brain electrical activity; (3) Those whose epileptic seizures affect the BIS signal; (4) Patients with poor signal quality of BIS detection data and obvious signal interference. 2. The exclusion criteria for BIS assessment of the degree of coma and prognosis in patients with chronic disturbance of consciousness are as follows: (1) Obvious cognitive impairment and severe stroke sequelae before the onset affect the BIS value; (2) Severe acidosis, endocrine disorders, electrolyte disorders, hypothermia, hyperthermia, etc. significantly affect brain electrical activity; (3) Patients with epilepsy; (4) Patients with poor signal quality of BIS detection data and obvious signal interference.

Design outcomes

Primary

MeasureTime frame
Correlation between BIS value in acute phase and 1-month GOS-e score outcome;Correlation between 1-3 months BIS value and 12-month GOS-e score outcome in DOC patients;

Secondary

MeasureTime frame
Correlation analysis of BIS value with GCS score, APACHE II score and blood flow detected by TCD in patients with acute severe brain injury;Correlation analysis of BIS value with crs-r score, EEG grading, P300 and TCD in patients with chronic disturbance of consciousness;

Countries

China

Contacts

Public ContactLin Kun

Fujian Provincial Hospital South Branch

13850141944@163.com+86 13850141944

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026