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Optical Assessment on Brain Death Via a Oxygen Supply Procedure

Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03864887
Enrollment
80
Registered
2019-03-06
Start date
2019-02-11
Completion date
2019-12-31
Last updated
2019-03-06

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

Conditions

Brain Death

Keywords

Brain death, Oxygen metabolism, Near infrared spectroscopy

Brief summary

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.

Detailed description

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.

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).

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).

DEVICEOptical monitor for hemodynamic parameter.

Near infrared spectroscopy probes of tow wavelengths were attached on the subjects' foreheat 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. * 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