Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy

Chinese Academy of Medical Sciences75 enrolled

Overview

This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ\[HbO2\] (the concentration changes in oxy-hemoglobin) and Δ\[Hb\] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. 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, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Death Coma

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). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters.

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). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead 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. * Patients who have deep coma with autonomous respiration according to GCS coma Scale * 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

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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