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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Coma; Brain Death

Treatments: Procedure: Oxygen supply of low-high-low procedure; Procedure: Oxygen supply of high-low-high procedure

Study type: Observational

Funder types: Other

Identifiers

NCT04623294

NIRS for brain death and coma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 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.
• 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

Trial design

75 participants in 6 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 the NIRS instrument for hemodynamic parameter.

Treatment:

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 the NIRS instrument for hemodynamic parameter.

Treatment:

Procedure: Oxygen supply of low-high-low procedure

Deep coma patients for HLH Oxygen

Description:

Deep coma 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 the NIRS instrument for hemodynamic parameter.

Treatment:

Procedure: Oxygen supply of high-low-high procedure

Deep coma patients for LHL Oxygen

Description:

Deep coma 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 the NIRS instrument for hemodynamic parameter.

Treatment:

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:

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:

Procedure: Oxygen supply of low-high-low procedure