Optical Assessment on Brain Death Via a Oxygen Supply Procedure

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Brain Death

Treatments: Device: Optical monitor for hemodynamic parameter.; Procedure: Oxygen supply of low-high-low procedure; Procedure: Oxygen supply of high-low-high procedure

Study type: Observational

Funder types: Other

Identifiers

NCT03864887

Brain Death of AMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Brain death patients for HLH Oxygen

Description:

Brain-dead patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of high-low-high procedure. During the procedures, the Δ\[Hb\] and Δ\[HbO2\] time courses were collected by Optical monitor for hemodynamic parameter.

Treatment:

Device: Optical monitor for hemodynamic parameter.

Procedure: Oxygen supply of high-low-high procedure

Brain death patients for LHL Oxygen

Description:

Brain-dead patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of low-high-low procedure. During the procedures, the Δ\[Hb\] and Δ\[HbO2\] time courses were collected by Optical monitor for hemodynamic parameter.

Treatment:

Device: Optical monitor for hemodynamic parameter.

Procedure: Oxygen supply of low-high-low procedure

Healthy people for HLH Oxygen

Description:

Healthy people were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of high-low-high procedure. During the procedures, the Δ\[Hb\] and Δ\[HbO2\] time courses were collected by Optical monitor for hemodynamic parameter.

Treatment:

Device: Optical monitor for hemodynamic parameter.

Procedure: Oxygen supply of high-low-high procedure

Healthy people for LHL Oxygen

Description:

Healthy people were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of low-high-low procedure. During the procedures, the Δ\[Hb\] and Δ\[HbO2\] time courses were collected by Optical monitor for hemodynamic parameter.

Treatment:

Device: Optical monitor for hemodynamic parameter.

Procedure: Oxygen supply of low-high-low procedure