Optical Assessment on Brain Death Via a Oxygen Supply Procedure

Chinese Academy of Medical Sciences80 enrolled

Overview

This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

Brain death is an irreversible loss of all brain functions, and the assessment is crucial for organ supply for transplantation. The noninvasive, sensitive, universally available and timely ancillary method to assess brain death has not been established. This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment. The concentration changes ratios of oxyhemoglobin to deoxyhemoglobin (Δ\[HbO2\]/Δ\[Hb\]) in the cerebral cortex of brain-dead patients were significantly higher than those of healthy subjects.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Death

Interventions

Oxygen supply of high-low-high procedurePROCEDURE

The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 60% FIO2 (phase I, high oxygen), half-hour measurement at 40% FIO2 (phase II, low oxygen) and half-hour measurement at 60% FIO2 (phase III, high oxygen).

Oxygen supply of low-high-low procedurePROCEDURE

The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 40% FIO2 (phase I, low oxygen), half-hour measurement at 60% FIO2 (phase II, high oxygen) and half-hour measurement at 40% FIO2 (phase III, low oxygen).

Optical monitor for hemodynamic parameter.DEVICE

Near infrared spectroscopy probes of tow wavelengths were attached on the subjects' foreheat to detect the changes of hemodynamic parameters.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have had brain death or serious brain trauma. * Healthy people who are interested in optical assessment of hemodynamic parameters Exclusion Criteria: * Patients who are in pregnancy or have plan to conception. * Patients who have vertebra surgery or have plan of surgery. * Patients who are inappropriate to join this trial judged by the radiologists or specialists. * AIDS, Active Hepatitis, Tuberculosis, Syphilis * Patients who regularly take anticoagulants, antiplatelet drugs

Locations (1)

NIRS assessment for brain death

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Δ[HbO2]

The changes of oxyhemoglobin concentrations in prefrontal cortex.

Time frame: 1 day during the whole experiment

Δ[Hb]

The changes of deoxyhemoglobin concentrations in prefrontal cortex.

Time frame: 1 day during the whole experiment

Secondary Outcomes

Heart rate

Heart rate of patient recorded by bed-side physiological monitor.

Time frame: 1 day during the whole experiment

Blood pressure

Blood pressure of patient recorded by bed-side physiological monitor.

Time frame: 1 day during the whole experiment

Data from ClinicalTrials.gov

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