Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)

NCT ID: NCT06932640

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-12-31

Brief Summary

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The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).

Detailed Description

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysmal subarachnoid hemorrhage (SAH) patients

The study will be conducted on patients aged 18 to 89 years admitted to the Neurological Intensive Care Unit (ICU) with a Aneurysmal subarachnoid hemorrhage (SAH). The study will use near-infrared spectroscopy (NIRS) monitors (which is outside standard of care) and transcranial doppler (TCD, only when available and is standard of care) that will be attached to these patients. The data from these devices will be used solely for analysis after the patients have been discharged.

- Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)

Intervention Type DEVICE

Near-Infrared Spectroscopy (NIRS) monitors, provided by Edwards Lifesciences, is a monitoring technique. It will be connected to consented patients, automatically capturing brain oxygen as waveform output, and stored in Sickbay system. The NIRS is a non-invasive monitoring method, in which adhesive pads will be applied to forehead. 4 hours continuous monitoring will be recorded on day 1 after SAH (or on presence to NICU), then every three days from day 3 to day 14 (within the DCI window), to 1 to 2 recordings from day 15 to day 21.

Interventions

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- Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)

Near-Infrared Spectroscopy (NIRS) monitors, provided by Edwards Lifesciences, is a monitoring technique. It will be connected to consented patients, automatically capturing brain oxygen as waveform output, and stored in Sickbay system. The NIRS is a non-invasive monitoring method, in which adhesive pads will be applied to forehead. 4 hours continuous monitoring will be recorded on day 1 after SAH (or on presence to NICU), then every three days from day 3 to day 14 (within the DCI window), to 1 to 2 recordings from day 15 to day 21.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 to 89 years who are admitted to the Neurological Intensive Care Unit (Neuro ICU) between March 2025 and December 2026 for aneurysmal subarachnoid hemorrhage (SAH).

Exclusion Criteria

* Patients under 18 years old
* Prisoners
* Pregnant women
* Patients enrolled in concurrent ongoing interventional trial
* Students of UAB
* Employees of UAB
* Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Weifeng Song

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weifeng Song, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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LaShun L. Horn, M.S.

Role: CONTACT

205-996-2606

Facility Contacts

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Weifeng Song, M.D., Ph.D

Role: primary

205-934-4699

Other Identifiers

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Pending

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300014488

Identifier Type: -

Identifier Source: org_study_id

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