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A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma

A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06404645
Acronym
NIRS-DETECT
Enrollment
20
Registered
2024-05-08
Start date
2024-05-01
Completion date
2024-12-31
Last updated
2024-05-08

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

Conditions

Intracranial Hemorrhages

Brief summary

This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS)detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.

Interventions

DEVICENear-infrared spectroscopy detection

Cranial CT confirm intracranial haematoma. Then the near-infrared spectroscopy device to collect date by red sensor probe in the corresponding position on the scalp and blue sensor probe on the opposite side of the hematoma. Collect data for 10 minutes.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age above 18 years old 2. Unilateral subcranial hemorrhage confirmed by cranial CT

Exclusion criteria

1. Bilateral subcranial hemorrhage 2. Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT 3. Obvious skull fracture in the location of hemorrhage on cranial CT

Design outcomes

Primary

MeasureTime frameDescription
NIRS data13 monthsNIRS data of bleeding side and the opposite side

Secondary

MeasureTime frameDescription
NIRS data23 monthsrelationship between NIRS data and thickness of haematoma

Countries

China

Contacts

Primary ContactRu Gong
gongru1987@126.com13512193229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026