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A single-center prospective randomized controlled study of wearable mixed-reality holographic computer for guiding Intracerebral hematoma drain insertion

A single-center prospective randomized controlled study of wearable mixed-reality holographic computer for guiding Intracerebral hematoma drain insertion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046370
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Intracranial hemorrhage

Interventions

Group 1:Intracerebral hematoma drain insertion guided by wearable mixed-reality holographic computer
Group 2:Intracerebral hematoma drain insertion guided by stereotaxis

Sponsors

Chongqing Emergency Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. There is no gender limit, and aged 18 to 75 years; 2. It is confirmed by CT scan that the volume of the supratentorial hematoma >=30mL or the volume of the subtentorial hematoma >=10ml; 3. Glasgow Coma Scale (Glasgow Coma Scale, GCS) score .= 5; 4. The patient was admitted to the hospital within 24 hours of onset; 5. No coagulation dysfunction, platelet count> 50 x 10^9 / L and prothrombin time extension <5 seconds; 6. The general condition of the patient is fair, the cardiopulmonary function can tolerate surgical treatment, and there is no absolute contraindication for brain surgery; 7. The patient or his family (when the patient is in the hospital) provide written consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Complicated with head trauma or history of head injury; 3. There are multiple hemorrhagic lesions; 4. Patients suffering from severe dementia or disability; 5. There are signs of terminal herniation; 6. Patients suffering from concomitant diseases, these diseases will affect their life expectancy; 7. The main body of the hematoma is located in the ventricular system; 8. Foreign, Hong Kong, Macau, Taiwan or other regions, it is estimated that it is difficult to follow up and follow up after surgery.

Design outcomes

Primary

MeasureTime frame
The offset distance between the actual puncture target point and the scheduled puncture target point for each patient;

Secondary

MeasureTime frame
Operation time;Number of punctures;The degree of hematoma clearance after the first puncture drainage;The degree of hematoma clearance after extubation;Relevant indicators for recent recovery;Long-term prognosis related indicators;

Countries

China

Contacts

Public ContactDeng Yongbing

Chongqing Emergency Medical Center

1422495819@qq.com+86 13996267066

Outcome results

None listed

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