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

Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04623294
Enrollment
75
Registered
2020-11-10
Start date
2020-11-10
Completion date
2022-12-31
Last updated
2020-11-10

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

Conditions

Brain Death, Coma

Keywords

Brain death, Deep coma, Oxygen metabolism, Near infrared spectroscopy

Brief summary

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.

Detailed description

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.

Interventions

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.

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.

Sponsors

Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Δ[HbO2]1 day during the whole experimentThe changes of oxyhemoglobin concentrations in prefrontal cortex.
Δ[Hb]1 day during the whole experimentThe changes of deoxyhemoglobin concentrations in prefrontal cortex.

Secondary

MeasureTime frameDescription
Heart rate1 day during the whole experimentHeart rate of patient recorded by bed-side physiological monitor.
Blood pressure1 day during the whole experimentBlood pressure of patient recorded by bed-side physiological monitor.

Countries

China

Outcome results

None listed

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