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Near Infra-red Spectroscopy for Detection of Intracranial Haematoma

NCT03653728 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-07-29

No results posted yet for this study

Summary

Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.

Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these noninvasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources. Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as nearinfrared spectroscopy (NIRS) is to be investigated.

The aim of this study is to determine the sensitivity and specificity of NIRS as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain. Study design is Prospective sensitivity and specificity study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited. Outcome measures including correlation of non-invasive monitoring with near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect. Secondary outcome including 30 days mortality and functional outcome at 3 months.

Conditions

Interventions

DEVICE

Near infrared spectroscopy

All patients would be receiving the same treatment including application of non-invasive monitoring with near-infrared spectroscopy (NIRS) together with the standard of care with interval CT Brain scan for all patients. Non-invasive monitoring with near-infrared spectroscopy (NIRS) is very safe and is in current daily routine clinical use for intraoperative patients.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653728 on ClinicalTrials.gov