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

• Conditions: Brain Death; Coma
• Interventions: Procedure: Oxygen supply of low-high-low procedure; Procedure: Oxygen supply of high-low-high procedure

• Registration Number: NCT04623294
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Last Update Submitted: 2020-11-09
• Study Start: 2020-11-10
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-03-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy people for LHL Oxygen	Oxygen supply of low-high-low procedure	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.
Deep coma patients for HLH Oxygen	Oxygen supply of high-low-high procedure	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.
Brain death patients for LHL Oxygen	Oxygen supply of low-high-low procedure	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.
Brain death patients for HLH Oxygen	Oxygen supply of high-low-high procedure	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.
Deep coma patients for LHL Oxygen	Oxygen supply of low-high-low procedure	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.
Healthy people for HLH Oxygen	Oxygen supply of high-low-high procedure	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.

Primary Outcome Measures

Name	Time	Method
Δ[HbO2]	1 day during the whole experiment	The changes of oxyhemoglobin concentrations in prefrontal cortex.
Δ[Hb]	1 day during the whole experiment	The changes of deoxyhemoglobin concentrations in prefrontal cortex.

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 day during the whole experiment	Heart rate of patient recorded by bed-side physiological monitor.
Blood pressure	1 day during the whole experiment	Blood pressure of patient recorded by bed-side physiological monitor.

Trial Locations

Locations (1)

NIRS assessment for brain death; 🇨🇳 Tianjin, Tianjin, China