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Clinical study for non-invasive assessment of intracranial pressure by waveform analysis of central aortic pressure and cerebral blood flow

Clinical study for non-invasive assessment of intracranial pressure by waveform analysis of central aortic pressure and cerebral blood flow

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024154
Enrollment
Unknown
Registered
2019-06-28
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

traunaric brain injury

Interventions

pressure&#32
waveform,&#32
hemodynamics.
Gold Standard:Invasive intracranial pressure
Index test:the&#32

Sponsors

Ruijin Hospital North, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with acute craniocerebral injury admitted to the neurosurgical ward or intensive care unit within 48 hours after injury; 2. Moderate or severe craniocerebral injury diagnosed according to GCS score. 3. Age 18-75 years old, gender not limited; 4. Patients with acute and medium-sized craniocerebral trauma who are found to have intracranial abnormalities (intracranial hemorrhage, cerebral contusion and laceration, cerebral edema, cerebral swelling, hydrocephalus, basal cistern compression, etc.) by head CT examination, and those with indications for invasive intracranial pressure detection; 5. This study has been approved by the ethics committee of ruijin hospital affiliated to Shanghai jiaotong university school of medicine; 6. Explain the clinical trials to the patients or their families, and provide effective informed consent.

Exclusion criteria

Exclusion criteria: 1. Refractory severe intracranial hypertension; 2. The temporal window is completely closed, unable to detect blood flow signals; 3. Shock and severe compound injury; 4. Pregnant or lactating women; 5. Serious systemic diseases already existed at the time of admission: severe infection, diseases of the blood system, severe heart, liver and kidney dysfunction or patients with previous tumors; 6. Patients who died during treatment.

Design outcomes

Primary

MeasureTime frame
central aortic pressure waveform;invasive intracranial pressure;cerebral hemodynamics;SEN, SPE, ACC, AUC of ROC, Kappa coefficient;

Countries

China

Contacts

Public ContactJunli Zuo

Ruijin Hospital North, Shanghai Jiaotong University School of Medicine

zuo-junli@163.com+86 18121263127

Outcome results

None listed

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